FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984513
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00286
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 29, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ICD TREATMENT WAS INADEQUATE DURING CARDIAC CONTRACTILITY MODULATION STIMULATION. UPON REVIEW OF DATA AND SESSION RECORDS, THE VF EPISODE WAS FOUND TO BE DUE TO NOISE COUPLED WITH BOTH SENSED AND PACED VENTRICULAR COMPLEXES. LEAD DAMAGE SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88603 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |