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 2018-12-03 for STIMLOC 924256 manufactured by Medtronic Neuromodulation.
[129029799]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[129029800]
Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins). It was reported during the application of the sitmloc base rings, the screws were blunt and one screw broke. The base rings were too difficult to apply with the supplied screws. No environmental/external/patient factors were thought to have led or contributed to the issue. The screws were visually inspected and they described tactile feedback. The screws were taken out and they used a spare stimloc kit to replace the parts. The issue was resolved at the time of the report. It caused a delay of 10-15 minutes. It was reported they were unable to retrieve the parts of the broken screw. The patient had a medical history of parkinson's disease. The patient was alive without injury at the time of the report. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
[134112097]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[134112098]
Additional information received from the manufacturer? S representative (rep), which was confirmed with the healthcare provider (hcp), reported the device was going to be returned for analysis (a tracking number was provided). No further complications were anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2018-03476 |
| MDR Report Key | 8123981 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-03 |
| Date of Report | 2019-01-23 |
| Date of Event | 2018-11-29 |
| Date Mfgr Received | 2019-01-15 |
| Date Added to Maude | 2018-12-03 |
| 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 | 2018-12-03 |
| Returned To Mfg | 2019-01-30 |
| 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. Other | 2018-12-03 |