MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-01-04 for ACTIVA 37601 manufactured by Medtronic Puerto Rico Operations Co..
[63870096]
Section information references the main component of the system, other applicable components are: product id 3387s-40 lot# va0k227 serial# implanted: (b)(6) 2014 explanted: product type lead product id 3387s-40 lot# va0k227 serial# implanted: (b)(6) 2014 explanted: product type lead. 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
[63870097]
Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for obsessive compulsive disorder (ocd) and movement disorders. It was reported that an impedance measurement was taken prior to an eeg being performed on the patient. The impedance measurement resulted in electrodes 8 <(>&<)> 9 having values of 26 ohms; a short was reported. It was confirmed that the patient was programmed on c and 8- so the battery and therapy were not affected. Follow-up with the rep indicated that no troubleshooting was performed to determine the cause of the short as the patient was at a mri facility to receive a brain scan. It was also stated that there were no actions on the rep's part to resolve the issue as the patient was not programmed on that particular contact and was receiving therapy without any issues. It is unknown if the impedance issue has resolved. No symptoms were reported.
Patient Sequence No: 1, Text Type: D, B5
[102609181]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2017-00208 |
| MDR Report Key | 6222982 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-01-04 |
| Date of Report | 2017-01-04 |
| Date of Event | 2016-12-09 |
| Date Mfgr Received | 2016-12-09 |
| Device Manufacturer Date | 2015-06-26 |
| Date Added to Maude | 2017-01-04 |
| 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 | 2017-01-04 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| Device Expiration Date | 2016-12-14 |
| 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 | 2017-01-04 |