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 2018-10-01 for STIMLOC 924256 manufactured by Advanced Uro-solutions, L.l.c..
[122191950]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[122191951]
Information was received from a healthcare provider about a patient with an implantable neurostimulator (ins) for unknown indications for use. It was reported that during the implant of a lead the burr hole cover cracked. There were no symptoms reported. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012165443-2018-00011 |
| MDR Report Key | 7922501 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-01 |
| Date of Report | 2018-10-01 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-09-26 |
| Date Added to Maude | 2018-10-01 |
| 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 | 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 | 2018-10-01 |
| Model Number | 924256 |
| Catalog Number | 924256 |
| Lot Number | 082205818A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-10-01 |