MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-01-27 for ACTIVA 37612 manufactured by Medtronic Puerto Rico Operations Co..
[66011537]
Patient Sequence No: 1, Text Type: N, H10
[66011538]
Information was received from a healthcare professional and consumer via a manufacturer representative regarding a patient implanted with a neurostimulator (ins) for obsessive compulsive disorder and movement disorders. It was reported that patient was seeing an out-of-regulation (oor) message when using the patient programmer. It was reported that the healthcare professional gave the patient a range of 3. 1? 3. 9 volts, but the patient can only increase up to 0. 5 volts. It was noted that the patient does not have access to change parameters. No patient symptoms were reported.
Patient Sequence No: 1, Text Type: D, B5
[66896813]
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
[66896814]
Additional information was received. It was reported that the ins was checked with the patient programmer and it was determined that the battery had been turned off. It was reported that the patient had turned down stimulation and turned the battery off with the programmer. It was reported that the battery was turned back on, stimulation was set to 3. 5 v and the device was charged to 75%.
Patient Sequence No: 1, Text Type: D, B5
[101996978]
Corrected information: sex, date of birth. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101996979]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2017-01946 |
| MDR Report Key | 6283757 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-01-27 |
| Date of Report | 2017-02-08 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2017-01-30 |
| Device Manufacturer Date | 2016-01-29 |
| Date Added to Maude | 2017-01-27 |
| 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 | 2017-01-27 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Device Expiration Date | 2016-12-28 |
| 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 | 2017-01-27 |