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 2019-01-10 for STIMLOC 924256 manufactured by Advanced Uro-solutions, L.l.c..
[132941172]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[132941173]
Information was received from a healthcare provider (hcp) regarding a patient who was implanted with a neurostimulator (ins) for movement disorders. It was reported that the inner clip of the stimloc was not holding the dbs lead. After clipping the lead it pulled back a couple of cm and had to be put back in place. O arm scan at the end confirmed that the lead was relocated to the correct depth. The clip was repositioned but was still not holding the lead as well as usual. The stimloc cal was then put in to further secure the lead. The issue was resolved. There were no further complications reported.
Patient Sequence No: 1, Text Type: D, B5
[133360716]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[133360717]
Additional information received from the manufacturer? S representative (rep), which was confirmed with the healthcare provider (hcp), reported there was no reason for the clip not holding. The clip was still implanted and would not be returned. No further patient symptoms or complications were anticipated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012165443-2019-00001 |
| MDR Report Key | 8237428 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-17 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2019-01-10 |
| 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 | 2019-01-10 |
| Model Number | 924256 |
| Catalog Number | 924256 |
| Lot Number | 082225418A |
| 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 | 1. Required No Informationntervention | 2019-01-10 |