MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-18 for SWIFT-LOCK ANCHOR 1192 manufactured by St. Jude Medical - Neuromodulation.
[183934276]
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
[183934277]
Related manufacturer report number: 1627487-2020-02809, 3006705815-2020-01212, 3006705815-2020-01211. It was reported that the patient had an infection at the lead site. The patient was treated with antibiotics, but the infection did not clear. As a result, surgical intervention took place wherein the entire system was explanted.
Patient Sequence No: 1, Text Type: D, B5
[188144076]
As a result, a device history record was performed to review and confirm the sterility of the lead(s). Based on the documents reviewed, the source of the infection remains unknown.
Patient Sequence No: 1, Text Type: N, H10
[188916554]
Additional information was received stating that the infection has resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2020-02810 |
| MDR Report Key | 9848807 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-01-19 |
| Date Added to Maude | 2020-03-18 |
| 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 | ANCHOR |
| Product Code | GZB |
| Date Received | 2020-03-18 |
| Model Number | 1192 |
| Catalog Number | 1192 |
| Lot Number | 6803434 |
| 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 | 2020-03-18 |