FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION LEAD
MDR report key: 1073126
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02368
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 14, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- 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
THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY DEVICE CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. NORMAL LEAD IMPEDANCE WAS MEASURED. MECHANICAL AND VISUAL ANALYSIS FOUND DRIED BODY FLUID/TISSUE INSIDE THE HEADER AND INSIDE THE DISTAL INSULATION/COIL, PREVENTING HELIX ACTUATION. THE ENSUING RESISTANCE MAY HAVE RESULTED IN AN OVER-TORQUE CONDITION. THERE WAS NO INDICATION OF DEFECTS IN MATERIALS OR WORKMANSHIP.
Description of Event or Problem · 1
THE LEAD WAS EXPLANTED WHEN A DROP IN SENSING AND AN INCREASE IN IMPEDANCE WERE OBSERVED. A LEAD ANOMALY WAS SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |