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 2019-05-17 for STIMLOC 924256 manufactured by Medtronic Neuromodulation.
[145387224]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[145387225]
Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for the treatment of essential tremor and movement disorders. It was reported during the procedure after lead was placed, the stimloc clip was inserted and the gate was shut around the lead however the surgeon noticed that the lead was still able to move freely despite the shut gate. The cause of the issue was unknown. It was replaced the stimloc clip with a new one which seems to hold the lead well. The issue was resolved at the time of the report. The patient was alive without injury at the time of the report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-01085 |
| MDR Report Key | 8620151 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-05-15 |
| Date Mfgr Received | 2019-05-15 |
| Device Manufacturer Date | 2018-11-26 |
| Date Added to Maude | 2019-05-17 |
| 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 | 2019-05-17 |
| Model Number | 924256 |
| Catalog Number | 924256 |
| Lot Number | 082233018A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-05-17 |