FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 3220161
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04247
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 29, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE CHANGE OUT, HIGH PACING LEAD IMPEDANCE AND LOSS OF CAPTURE WERE OBSERVED WHEN CONNECTED TO THE NEW DEVICE. NO ELECTRICAL ANOMALIES WERE NOTED WITH THE OLD DEVICE. LEAD FRACTURE WAS SUSPECTED. LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321093 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |