FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1073112
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02354
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- February 15, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED 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. MECHANICAL AND VISUAL ANALYSIS FOUND THE HELIX AND INNER INSULATION CLOGGED WITH DRIED FULL STYLET INSERTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS EXPLANTED WHEN AN INCREASE IN PACING THRESHOLD WAS OBSERVED. THERE WERE 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 | 1582/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |