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 2020-03-06 for SWIFT-LOCK ANCHOR 1192 manufactured by St. Jude Medical - Neuromodulation.
[182362369]
During the process of complaint, attempts were made to obtain complete event information for treatment, but not available. The results/method and conclusion codes along with the investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[182362370]
Device 4 of 5. Reference mfr. Report: 3006705815-2020-01025, 3006705815-2020-01026, 3006705815-2020-01027, 1627487-2020-02404. It was reported the patient had a suspected infection at an unknown location and the entire scs system was explanted. There was no complications observed during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[186634742]
A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event. Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. It was inadvertently reported the patient code as (b)(4) in initial report. The correct code has been updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1627487-2020-02403 |
| MDR Report Key | 9799329 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-06-07 |
| Date Added to Maude | 2020-03-06 |
| 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 | 2020-03-06 |
| Model Number | 1192 |
| Catalog Number | 1192 |
| Lot Number | 7010944 |
| 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 | 2020-03-06 |