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 7120Q/65 7120Q-65 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185695595]
No complaint was received with the return of the device. Failure event observed during analysis. Only the connector portion of the lead was returned in one piece. Analysis revealed an external abrasion was found breaching the optim sheath and insulation exposing the right ventricle (rv) cables caused by friction to the device can [noted at 18. 2 cm to 18. 7 cm from the connector pin]. The etfe coating on the cables was found undamaged. Abrasion caused by clavicle crush was noted breaching the [re and rv cable lumens and the optim sheath at 32. 2 cm to 32. 6 cm from the connector pin] and [svc cable lumen and the optim sheath at 32. 0 cm to 32. 4 cm from the connector pin] exposing all of the cable lumens and cables. The etfe coating on all cables was found undamaged. *re (ring electrode), rv (right ventricular), etfe (ethylene tetrafluoroethylene), svc (superior vena cava).
Patient Sequence No: 1, Text Type: N, H10
[185695596]
This report is to advise of an event observed during analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-04401 |
| MDR Report Key | 9900890 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2014-01-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 |
| Returned To Mfg | 2020-02-18 |
| Model Number | 7120Q/65 |
| Catalog Number | 7120Q-65 |
| Lot Number | 4420175 |
| Device Expiration Date | 2015-01-31 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-30 |