FDA Adverse Event
Malfunction
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 2984431
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00240
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- October 22, 2012
- 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
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. AN INTERNAL INSULATION ABRASION WAS FOUND UNDER THE SVC SHOCK COIL AT 24.4CM-25.2CM FROM THE TIP. THE ETFE COATING OF THE RV CONDUCTOR WAS ABRADED AT THIS LOCATION. THIS DAMAGE COULD HAVE CAUSED THE REPORTED LOW SHOCK IMPEDANCE IF THE DAMAGED RV CONDUCTOR CONTACTED THE SVC SHOCK COIL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED A PATIENT NOTIFIER FOR OUT OF RANGE HV LEAD IMPEDANCE. UPON INTERROGATION, LOW HV LEAD IMPEDANCE WAS OBSERVED. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89075 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |