FDA Adverse Event
Injury
Summary report: N
RIATA ST PASSIVE FIXATION
MDR report key: 1010658
·
Received March 10, 2008
Report
- Report Number
- 2017865-2008-01149
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- January 23, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LEAD INSULATION WAS ABRADED BETWEEN 17 CM AND 19 CM FROM THE CONNECTOR PIN DUE TO ABRASION WITH THE CAN. RV COIL WAS COMPRESSED AT THE PROXIMAL END OF THE COIL. IT IS UNLIKELY THAT ANY OF THE OBSERVED DAMAGES ON THE LEAD COULD CAUSE THE REPORTED VARIATION IN SENSING. AS THE DISTAL PART WAS NOT RECEIVED, A COMPLETE ANALYSIS COULD NOT BE PERFORMED. NORMAL ELECTRICAL CHARACTERISTICS WERE MEASURED.
Description of Event or Problem · 1
AFTER THE INITIAL REPOSITION IN (B) (6) 2007, THE PATIENT REPORTED CHEST PAIN. THE LEAD WAS FOUND TO HAVE FALLEN INTO THE SAME HOLE AS THE INITIAL PERFORATION, CAUSING ANOTHER PERFORATION. THE LEAD WAS EXPLANTED AND REPLACED WITH A PASSIVE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST PASSIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7042/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |