FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1073498
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02397
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 30, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY DEVICE CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED HIGH THRESHOLD AND SENSING ANOMALY. ANALYSIS FOUND THE OUTER INSULATION DAMAGED AND A SVC CABLE FRACTURED, WHICH APPEAR TO HAVE BEEN EXPOSED TO AN EXTERNAL MECHANICAL FORCE CONSISTENT WITH THAT OCCURRING AT THE TIME OF SURGICAL PROCEDURE. THE DAMAGES OBSERVED WOULD NOT HAVE CONTRIBUTED THE REPORTED EVENT. THE CONDITION OF THIS DEVICE WAS NOT FOUND TO BE A RESULT OF DEFICIENCY IN MATERIALS OR WORKMANSHIP.
Description of Event or Problem · 1
AT FOLLOW-UP, AN INCREASE IN THRESHOLD AND DECREASE IN R-WAVE AMPLITUDE WERE OBSERVED. DURING LEAD REPOSITIONING, INSULATION DAMAGE WAS OBSERVED. AS SUCH, THE LEAD WAS EXPLANTED AND REPLACED WITH NO CONSEQUENCES TO THE PATIENT.
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 |