MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-04 for SWIFT-LOCK ANCHOR 1192 manufactured by St. Jude Medical - Neuromodulation.
[182043958]
Related mfr reports: 1627487-2020-02449, 1627487-2020-02450 and 1627487-2020-02452. It was reported the physician's office notified abbott the patient had an infection at or near the scs system lead incision site. Consequently, the patient's physician explanted the entire scs system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-02451 |
| MDR Report Key | 9789191 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2018-06-04 |
| Date Added to Maude | 2020-03-04 |
| 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 | 2020-03-04 |
| Model Number | 1192 |
| Catalog Number | 1192 |
| Lot Number | 6461508 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-04 |