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 2020-03-16 for SWIFT-LOCK ANCHOR 1192 manufactured by St. Jude Medical - Neuromodulation.
[183608654]
The results/method and conclusion codes along with investigation results will be provided on the final report.
Patient Sequence No: 1, Text Type: N, H10
[183608655]
Related manufacturer reference number 1627487-2020-02794 & 1627487-2020-02795. It was reported that the patient's anchor broke, resulting in the lead migrating. As a result, surgical intervention was taken to replace the devices.
Patient Sequence No: 1, Text Type: D, B5
[188440226]
The reported event of general damage was visually confirmed. As received the anchor had a breakage at the distal end. No checklist was initiated per 56-0258 as the complaint can be confirmed through visual inspection. The cause of fracture is consistent with the anchor being subjected to overstress while in vivo.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1627487-2020-02793 |
| MDR Report Key | 9837023 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-16 |
| 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 | ANDREA DEITZ |
| Manufacturer Street | 6901 PRESTON ROAD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723098000 |
| Manufacturer G1 | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Street | 6901 PRESTON RD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWIFT-LOCK ANCHOR |
| Generic Name | SCS ANCHOR |
| Product Code | GZB |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 1192 |
| Catalog Number | 1192 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Address | 6901 PRESTON RD PLANO TX 75024 US 75024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |