MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for RIATA ACTIVE FIXATION 1580/65 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[185713734]
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
[185713735]
Related manufacturer reference number: 2938836-2020-02306. Related manufacturer reference number: 2938836-2020-02308. It was reported that low frequency high amplitude noise was observed on atrial sense amp and ventricular sense amp channels. The lead impedance measurements were all within normal range. Patient presented for lead extraction and during the procedure, all 3 leads had insulation damage. It was unclear if the left ventricular lead was damaged during the extraction, but physician suspected lead was damaged prior to the extraction procedure. The patient was stable throughout the procedure.
Patient Sequence No: 1, Text Type: D, B5
[188749942]
The reported event of noise and insulation damage was not confirmed by analysis. During analysis, a failure event was observed which was unrelated to the reported event. Final analysis found internal insulation abrasion under the svc shock coil at 22. 6cm to 22. 7cm from the distal tip. The etfe coating was intact at this location.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2938836-2020-02307 |
| MDR Report Key | 9898350 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2007-05-16 |
| 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-SUNNYVALE) |
| Manufacturer Street | 645 ALMANOR AVENUE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIATA ACTIVE FIXATION |
| Generic Name | DEFIBRILLATION LEAD |
| Product Code | NVY |
| Date Received | 2020-03-30 |
| Model Number | 1580/65 |
| Lot Number | 0002159055 |
| Device Expiration Date | 2010-05-31 |
| 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-SUNNYVALE) |
| Manufacturer Address | 645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |