MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-01-07 for STIMLOC 924256 manufactured by Medtronic Neuromodulation.
[132259935]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[132259936]
Information was received by a manufacture representative (rep) regarding an implantable neurostimulator (ins) for movement disorders. It was reported that there was an ant epilepsy surgery. The patient was asleep for the case, the screw broke off, was removed and replaced. There were no known environmental factors that led to the issue. Backup green screws were used. The screws were retrieved and a new stimloc screw was used, and the issue had resolved. There were no further complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-00051 |
| MDR Report Key | 8223154 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-01-07 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-01-04 |
| Date Mfgr Received | 2019-05-10 |
| Date Added to Maude | 2019-01-07 |
| 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 | 3 |
| Brand Name | STIMLOC |
| Generic Name | COVER, BURR HOLE |
| Product Code | GXR |
| Date Received | 2019-01-07 |
| Returned To Mfg | 2019-01-10 |
| Model Number | 924256 |
| Catalog Number | 924256 |
| Lot Number | 082215217A |
| 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 | 1. Required No Informationntervention | 2019-01-07 |