FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 2083898
·
Received May 11, 2011
Report
- Report Number
- 2017865-2011-03445
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- September 13, 2010
- 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
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
THE DEVICE WAS UNABLE TO BE INTERROGATED. NO TELEMETRY COULD BE ESTABLISHED. THE DEVICE WAS EXPLANTED. ANALYSIS OF THE ICD REVEALED SUSPECTED LEAD DAMAGE. THE DEVICE MISDIAGNOSED NOISE AS FIB, CHARGED AND DEPLETED THE BATTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7001/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | (B)(4) |