FDA Adverse Event
Malfunction
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 1955063
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00029
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- September 29, 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 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
IT WAS REPORTED THAT AFTER THE ICD WAS ELECTIVELY REPLACED, THE LEAD EXHIBITED HIGH IMPEDANCE AND OVERSENSING. THE LEAD WAS MONITORED FOR A COUPLE OF DAYS AT WHICH TIME AN EPISODE OCCURRED LEADING TO A MISDIAGNOSIS. THE PHYSICIAN BELIEVED THE LEAD WAS DAMAGED. THE PHYSICIAN AND FAMILY DECIDED NOT TO DO ANOTHER SURGERY. THEREFORE, THE PARAMETERS WERE ADJUSTED AND THE PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |