FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984589
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00314
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 13, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT INAPPROPRIATE THERAPY DUE TO NOISE AND NO SENSING WERE OBSERVED. INTERROGATION OF THE DEVICE ALSO REVEALED ABORTED THERAPY. DURING THE EXPLANT PROCEDURE, THE LEAD BROKE AT THE LEVEL OF THE SVC COIL AND THE DISTAL PART OF THE LEAD REMAINS IMPLANTED. A NEW LEAD WAS IMPLANTED. THE PATIENT'S CONDITION WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85952 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |