MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-15 for ACTIVA 37612 manufactured by Medtronic Puerto Rico Operations Co..
[70105725]
Product id: 37612, serial#: (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.
Patient Sequence No: 1, Text Type: N, H10
[70105726]
It was reported that the patient got a? 00s00s? Error message on her controller on the day prior to report. It was noted that there were no acute changes in mood since error message. It was noted that the patient was charging at 75 percent. Additional information received reported that the patient had been seeing the same error message for 5-7 days. It was reported that the there was a complaint of an out of regulation (oor) error code. It was noted that the oor was occurring on the right side system and the patient had approximately 75 percent batteries on both of their implantable neurostimulators (ins)s. It was noted that the patient checked each ins with the patient programmer and turned the patient programmer off in between checking. Each time there was a reported oor on the right side but not the left side. It was noted that the patient turned off and then turned on the right side ins. It was noted that the after turning the device off and on the patient got a normal screen with no oor code. Additional information was received from a health care provider(hcp) of a clinical study via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for depression. It was reported that an out of regulation (oor) message was seen. It was reviewed that the message could be an indication of a potential system issue or an indication of high use parameters; it was unknown what the patient was doing when the oor message occurred. It was then stated that the implantable neurostimulator (ins) was still on and functioning , but the output may be slightly slower than programmed. The rep confirmed they were meeting with the health care provider (hcp) and the patient on the day of this report and would check the impedances. No symptoms were reported. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[71374399]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[71374400]
Additional information was received from a manufacturer representative (rep). It was reported that the patient's weight at the time of the event was unknown. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[73353614]
It was determined report number (3004209178-2017-05729) is a duplicate of report numbers 3004209178-2017-05638 and 3004209178-2017-05640. To this end, all additional information received will be submitted under report numbers 3004209178-2017-05638 and 3004209178-2017-05640. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[73353615]
The healthcare professional (hcp) via the manufacturer representative (rep) reported that the clinician programmer displayed the message that the delivered amplitude may be lower than the selected amplitude. It was stated the patient? S programmer displayed the call the doctor icon as well. No environmental/external/patient factors were described that may have led or contributed to the issue. The patient? S impedances were normal for both implantable neurostimulators (ins), and the patient was doing well with the therapy. It was stated the patient? S settings were not altered as a result of the message. The message appeared on one of the ins? S, but the hcp didn? T indicate whether it was the left or right ins. No action was taken as the patient was doing well and was having no other issues. It was further stated that the hcp didn? T know the reason for the message, but the patient was programmed on high amplitudes to achieve therapeutic benefit so that might be the cause for the message. It was unknown if the issues was resolved. The hcp may bring the patient back in at a future date to possibly alter the settings. The patient? S status at the time of the report was alive-no injury. The patient was implanted for depression. Additional information was received from a manufacturing representative. It was reported that the patient? S right ins continued to have the oor message displayed. Impedance checks were taken again and a short circuit was found between contacts 0 and 3 of 63ohms. The short circuit is not impacting the patient? S therapy. The patient? S healthcare provider will continue to monitor the impedances, and no further action is planned. No complications or further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[103219120]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2017-05640 |
| MDR Report Key | 6406337 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-15 |
| Date of Report | 2017-03-31 |
| Date of Event | 2014-06-18 |
| Date Mfgr Received | 2017-03-22 |
| Device Manufacturer Date | 2014-02-13 |
| Date Added to Maude | 2017-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MFR |
| Date Received | 2017-03-15 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Device Expiration Date | 2014-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-15 |