MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-09 for ACTIVA 3391S-40 manufactured by Mpri.
[77501054]
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
[77501055]
Information was received from a consumer via a manufacturer representative regarding a patient with an implantable neurostimulator. It was reported that the lead seemed more stiff than the others implanted that day. When the impedances were checked during implant electrode 3 showed out of range low < 50. The healthcare professional (hcp) then pulled the electrode out of the extension and wiped it off twice. They noticed there was a small wire coming out of the lead by the electrode. They then placed the lead back in the extension and did the test again in that electrode then showed over 10 ,000. The hcp did not want to remove the lead from the extension another time and they felt it would damage the integrity of the lead even more. The issue was resolved at the time of the report. There were no patient symptoms or further complications reported as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
[83761871]
Fdd (b)(4) no longer applies.
Patient Sequence No: 1, Text Type: N, H10
[97127638]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[99107123]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2649622-2017-07505 |
| MDR Report Key | 6630816 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-09 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-06-28 |
| Device Manufacturer Date | 2016-02-26 |
| Date Added to Maude | 2017-06-09 |
| 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 | MPRI |
| Manufacturer Street | ROAD 149 KM 56.3 |
| Manufacturer City | VILLALBA PR 00766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVA |
| Generic Name | DEEP BRAIN STIMULATOR FOR OBSESSIVE COMPULSIVE DISORDER |
| Product Code | OLM |
| Date Received | 2017-06-09 |
| Model Number | 3391S-40 |
| Catalog Number | 3391S-40 |
| Lot Number | VA14P8R |
| Device Expiration Date | 2018-12-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MPRI |
| Manufacturer Address | ROAD 149 KM 56.3 VILLALBA PR 00766 US 00766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-09 |