MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-26 for ACTIVA PC+S 37604 manufactured by Medtronic Puerto Rico Operations Co..
[76158151]
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
[76158152]
Information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep) regarding an unspecified amount patients who were implanted with a neurostimulator for obsessive compulsive disorder (ocd). It was reported that the batteries were depleting faster than anticipated. Each of the patient's batteries will need replacing within the trial period of 2 years, post-surgery. It was unknown when the event(s) began occurring. No symptoms were reported.
Patient Sequence No: 1, Text Type: D, B5
[96243969]
Upon review of the additional information received, it was determined that (b)(4) no longer applies. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[96243970]
Additional information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep). It was reported that using battery life estimator with a nominal set of parameters typically used with these patients, the duration of the battery was estimated to be about 2 years. Since these batteries require an additional drain for the sensing feature and this feature only being used during the clinic visits, the sensing feature would contribute to a 10% hit to the battery. It was then stated that given this information, the battery life that was reported did not seem to be wholly unexpected (within reason given the use case for these patients). It was also reported that no actions were taken at this time; no devices were explanted. However, one patient's device reached end of service (eos) after previously reaching elective replacement indicator (eri) on (b)(6) 2017, and will likely be explanted sometime soon. It was noted that the battery drain was within reasonable expectation. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[101598520]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101598521]
No new information was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2017-02052 |
| MDR Report Key | 6595166 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-26 |
| Date of Report | 2017-07-03 |
| Date of Event | 2017-05-11 |
| Date Mfgr Received | 2017-06-07 |
| Device Manufacturer Date | 2014-10-29 |
| Date Added to Maude | 2017-05-26 |
| 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 WOODWARD 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 MN 007771200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 007771200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVA PC+S |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MFR |
| Date Received | 2017-05-26 |
| Model Number | 37604 |
| Catalog Number | 37604 |
| Device Expiration Date | 2016-04-28 |
| 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 MN 007771200 US 007771200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-26 |