MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-01 for ACTIVA 3391 manufactured by Medtronic Neuromodulation.
[107197242]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[107197243]
Information was received from a healthcare professional via a manufacturer representative regarding a patient with an implantable neurostimulator (ins). It was reported during the procedure the physician implanted the lead then changed his mind and decided to use a different lead instead. Upon explant, the physician noticed one of the contacts appeared to be damaged upon visual inspection. The physician decided not to use the implant before the defect was noticed. The product was replaced. No environmental/external/patient factors were thought to have led to or contributed to the issue. The issue was resolved at the time of the report. The patient was alive without injury at the time of the report and no further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[107863409]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[108511810]
Analysis of the lead (lot # unknown) revealed no significant anomaly: stim lead/body/conductor crushed. However, electrical testing determined that continuity was complete and there were no electrical shorts between the circuits. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2018-01301 |
| MDR Report Key | 7476205 |
| Date Received | 2018-05-01 |
| Date of Report | 2018-05-16 |
| Date of Event | 2018-04-27 |
| Date Mfgr Received | 2018-05-11 |
| Date Added to Maude | 2018-05-01 |
| 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 NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACTIVA |
| Generic Name | DEEP BRAIN STIMULATOR FOR OBSESSIVE COMPULSIVE DISORDER |
| Product Code | OLM |
| Date Received | 2018-05-01 |
| Returned To Mfg | 2018-05-07 |
| Model Number | 3391 |
| Catalog Number | 3391 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-01 |