MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-22 for STIMLOC 924256 manufactured by Advanced Uro-solutions, L.l.c..
[136893616]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[136893617]
Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins). It was reported that the support clip did not fit properly into the base of the stimloc and it was not latching correctly, hindering the proper grip of the electrode. There were no external conditions that contributed to the issue. The defective stimloc was changed for another one, which worked correctly and the implant procedure was continued. No patient symptoms or further complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012165443-2019-00003 |
| MDR Report Key | 8362586 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-22 |
| Date of Report | 2019-06-07 |
| Date of Event | 2019-02-09 |
| Date Mfgr Received | 2019-06-06 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2019-02-22 |
| 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 | ADVANCED URO-SOLUTIONS, L.L.C. |
| Manufacturer Street | 7842 HICKORY FLAT HIGHWAY SUITE D |
| Manufacturer City | WOODSTOCK GA 30188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30188 |
| 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 | 2019-02-22 |
| Model Number | 924256 |
| Catalog Number | 924256 |
| Lot Number | 082224017A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED URO-SOLUTIONS, L.L.C. |
| Manufacturer Address | 7842 HICKORY FLAT HIGHWAY SUITE D WOODSTOCK GA 30188 US 30188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-22 |