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 2017-02-03 for ACTIVA 37612 manufactured by Medtronic Puerto Rico Operations Co..
[66548363]
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
[66548364]
Information was received from a manufacturing representative, healthcare provider and the patient with an implantable neurostimulator (ins) for obsessive compulsive disorder and movement disorders. It was reported that the patient was having poor coupling with the device on their left since (b)(6) 2017. The patient attempted to resolve the issue using the antenna locate feature but it did not resolve the issue. The patient reported that they did not have any bandages or swelling that may have been causing the issue. Additional information was received on (b)(6) 2017. One of the patients healthcare providers reported seeing an? Elective replacement indicator? (eri) message on the patients recharger a few days prior, even though the patient had the devices implanted on (b)(6) 2017. The nurse and the manufacturing representative were not able to replicate this message on the recharger or on the patient programmer. The patient has no issue with coupling on their right ins but is only getting 2 bars coupling on the left ins. The patient? S nurse ordered for images to be taken of the device. The images showed that the patient? S ins was flipped in the pocket. The patient decided that they did not want to go back into surgery to fix the issue, and will instead be more diligent about recharging the ins with only 2 coupling bars. There were no patient symptoms reported.
Patient Sequence No: 1, Text Type: D, B5
[68117241]
Patient Sequence No: 1, Text Type: N, H10
[68117242]
Additional information was received from a manufacturing representative. It was reported that the cause of the ins flip remains unknown.
Patient Sequence No: 1, Text Type: D, B5
[69240123]
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
[69240124]
Additional information was received from a manufacturing representative. It was reported that the patient underwent a revision surgery in which they had the ins sutured in again. There are no further problems.
Patient Sequence No: 1, Text Type: D, B5
[102364038]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2017-02533 |
| MDR Report Key | 6301243 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-02-03 |
| Date of Report | 2017-03-07 |
| Date of Event | 2017-01-20 |
| Date Mfgr Received | 2017-02-22 |
| Device Manufacturer Date | 2016-09-29 |
| Date Added to Maude | 2017-02-03 |
| 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 | 2017-02-03 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Device Expiration Date | 2017-08-28 |
| 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 | 1. Required No Informationntervention | 2017-02-03 |