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 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR 7122Q/58 7122Q-58 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185710838]
This product is registered as a combination product. Further information was requested but was not available.
Patient Sequence No: 1, Text Type: N, H10
[185710839]
Related manufacturer report number: 2017865-2020-04322. An initial report indicating a fracture and lead failure was received. Further investigation revealed the patient presented for a follow up (b)(6) 2020 during which no capture was present on the right ventricular lead. The patient returned on (b)(6) 2020 and capture was still not observed on the right ventricular lead. The patient was scheduled for an extraction. The right ventricular lead was explanted and replaced. The atrial lead was also explanted for unknown reasons. The patient returned for a follow up in clinic (b)(6) 2020 and was stable though shortness of breath was observed. The patient was diagnosed with thrombosis (b)(6) 2020 unrelated to the device and discharged (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-04323 |
| MDR Report Key | 9898332 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2013-09-19 |
| 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 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR |
| Generic Name | DEFIBRILLATION LEAD |
| Product Code | NVY |
| Date Received | 2020-03-30 |
| Model Number | 7122Q/58 |
| Catalog Number | 7122Q-58 |
| Lot Number | 4255857 |
| Device Expiration Date | 2014-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 |