MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-30 for RIATA ST ACTIVE FIXATION 7002/60 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185698266]
No complaint was received with the return of the device. Failure event observed during analysis. Final analysis found, as received, a partial lead (only the distal portion) returned measuring 46. 0/ 47. 9 cm (lead body insulation/ inner coil). Visual inspection found two internal insulation abrasion breaching the ring electrode cable lumen between right ventricular shock coil and suture sleeve tie impression with undamaged cable coating. The internal insulation abrasion breaching the re cable lumen was found at 7. 0 - 8. 0 cm and 23. 7? 24. 6 cm from the distal tip. The etfe coating found intact in these locations. Explant date unknown.
Patient Sequence No: 1, Text Type: N, H10
[185698267]
This report is to advise of an event observed during analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-04403 |
| MDR Report Key | 9900804 |
| Report Source | OTHER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2007-10-17 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0458-2012 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIATA ST ACTIVE FIXATION |
| Generic Name | DEFIBRILLATION LEAD |
| Product Code | NVY |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-02-25 |
| Model Number | 7002/60 |
| Lot Number | 0002236532 |
| Device Expiration Date | 2010-10-31 |
| 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 |