FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1223086
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03765
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 22, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ANALYSIS REVEALED THAT THE IS-1 PROXIMAL COIL WAS FRACTURED. THE LOCATION OF THE DAMAGE IS CONSISTENT WITH THAT CAUSED BY FRICTION WITH THE ICD CAN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPIES. PER PATIENT REQUEST, BOTH ICD AND LEAD WERE EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |