MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-12-28 for ACTIVA 37601 manufactured by Medtronic Puerto Rico Operations Co..
[63477753]
Concomitant medical products: product id: 37601, serial# (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator. 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
[63477754]
The patient reported that they are concerned their batteries are depleting faster than they have been told. It was stated that they checked the voltage with their patient programmer (pp), and the left implantable neurostimulator (ins) was at 2. 78, with the right one at 2. 68v. The left has also been depleting really fast and now at 2. 72 v. When the patient contacted the manufacturer representative (rep) in (b)(6) 2016 they were told they do not need a replacement for another year, with their healthcare provider (hcp) telling them they need the batteries now. Follow up with the hcp is to be conducted. The patient's indication for implant is obsessive compulsive disorder (ocd) and movement disorders. See related regulatory report 3004209178-2016-27328.
Patient Sequence No: 1, Text Type: D, B5
[100202338]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2016-27329 |
| MDR Report Key | 6210481 |
| Report Source | CONSUMER |
| Date Received | 2016-12-28 |
| Date of Report | 2016-12-28 |
| Date of Event | 2016-08-01 |
| Date Mfgr Received | 2016-08-01 |
| Device Manufacturer Date | 2014-03-03 |
| Date Added to Maude | 2016-12-28 |
| 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 | DIANE WOLF |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263987 |
| 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 | 2016-12-28 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| Device Expiration Date | 2015-08-28 |
| 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 | 2016-12-28 |