MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-17 for SWIFT-LOCK ANCHOR 1192 manufactured by St. Jude Medical - Neuromodulation.
[183724971]
Date of event is estimated. The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[183724972]
Related manufacturer reference number: 1627487-2020-02802, 1627487-2020-02804, 3006705815-2020-01208. It was reported the patient experienced pain at the anchor sites. Surgical intervention took place on (b)(6) 2020 wherein the anchors were explanted and replaced, and the leads were repositioned due to them moving during the replacement of the anchors.
Patient Sequence No: 1, Text Type: D, B5
[185627335]
No implanted devices were returned for evaluation. The event information pertaining to this incident has been reviewed and no product investigation can be performed as there are no complaint allegations present nor were the circumstances of the event attributed to the implanted system.
Patient Sequence No: 1, Text Type: N, H10
[185627336]
Additional information received indicates the pain has resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-02803 |
| MDR Report Key | 9841952 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2016-05-25 |
| Date Added to Maude | 2020-03-17 |
| 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 | 2020-03-17 |
| Model Number | 1192 |
| Catalog Number | 1192 |
| Lot Number | 5514919 |
| Device Expiration Date | 2018-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-17 |