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 2017-07-05 for ACTIVA PC+S 37604 manufactured by Medtronic Puerto Rico Operations Co..
[79037811]
(b)(6). 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
[79037812]
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 a neurostimulator or obsessive compulsive disorder (ocd). It was reported that the activa pc+s battery life did not last as long as anticipated so the device was surgically replaced with an activa pc. The diagnostic methods included monitoring the battery status. It was also stated that the event was resolved at the time of this report. There was no known impact or consequence to the patient. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5
[98437986]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[99112208]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[99112209]
Additional information received reported the cause of the battery not lasting as long as anticipated was not known.
Patient Sequence No: 1, Text Type: D, B5
[103554018]
No significant anomalies were found with the implantable neurostimulator (ins) battery. The device reached normal end of life and the telemetry and output were okay. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2017-14157 |
| MDR Report Key | 6685625 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-05 |
| Date of Report | 2017-09-12 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-09-01 |
| Device Manufacturer Date | 2014-10-29 |
| Date Added to Maude | 2017-07-05 |
| 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 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 PC+S |
| Product Code | MFR |
| Date Received | 2017-07-05 |
| Returned To Mfg | 2017-06-27 |
| Model Number | 37604 |
| Catalog Number | 37604 |
| Device Expiration Date | 2016-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-07-05 |