FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2984236
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00267
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 21, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WAS RETURNED CUT IN THREE SEGMENTS. INSULATION AND COIL DAMAGE WAS FOUND CONSISTENT WITH CLAVICLE CRUSH DAMAGE. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF OF HIGH LEAD IMPEDANCE.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN-HOSPITAL AFTER RECEIVING AN ALERT DUE TO HIGH IMPEDANCE. LEAD FRACTURE DUE TO POSSIBLE RIB-CLAVICLE CRUSH WAS NOTED. LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86651 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |