FDA Adverse Event
Injury
Summary report: N
RIATA ST PASSIVE FIXATION LEAD
MDR report key: 1073132
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02374
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 12, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- 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 THERE WAS APPARENT NOISE ON THE ATRIAL AND VENTRICULAR LEAD CHANNEL. THE NOISE ON THE VENTRICULAR CHANNEL LED TO INAPPROPRIATE HV THERAPY. IT WAS NOTED THAT THE PATIENT RAKES LEAVES EVERY DAY. THE PHYSICIAN COMMENTED AFTER INVASIVE INVESTIGATION THAT THE PATIENT'S LEADS WERE FRACTURED BY REPETITIVE MOTION AND EXTRANEOUS SHOULDER AND ARM MOVEMENT. THE ATRIAL LEAD WAS REMOVED, AND LEAD DAMAGE WAS CONFIRMED. THE VENTRICULAR LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST PASSIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7040/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |