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 2020-03-30 for OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR LDA220Q/58 LDA220Q-58 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185709651]
This product is registered as a combination product.
Patient Sequence No: 1, Text Type: N, H10
[185709652]
Related manufacturer number : 2017865-2020-03982; 2017865-2020-03983. It was reported that the patient presented with sepsis. Vegetation was present on the leads. The system was explanted due to infection (b)(6) 2020. The patient was cleared of infection and a replacement was authorized by infectious disease. A replacement system was implanted (b)(6) 2020. There were no complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-03984 |
| MDR Report Key | 9898263 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-06-12 |
| Date Added to Maude | 2020-03-30 |
| 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 | ELIZABETH BOLTZ |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR |
| Generic Name | DEFIBRILLATION LEAD |
| Product Code | NVY |
| Date Received | 2020-03-30 |
| Model Number | LDA220Q/58 |
| Catalog Number | LDA220Q-58 |
| Lot Number | A000081367 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |