FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1073506
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02400
- 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
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. THE HELIX EXTENSION WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. DRIED BODY FLUID/TISSUE INSIDE THE HEADER AND INNER INSULATION PREVENTED THE HELIX EXTENSION. AFTER CLEANING AND CUTTING, NORMAL HELIX MECHANISM WAS FOUND. THE DAMAGE FOUND IS CONSISTENT WITH THAT OCCURRING AT THE TIME OF THE SURGICAL PROCEDURE. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS DISLODGED. THE LEAD WAS REPLACED WHEN A REPOSITION WAS UNSUCCESSFUL.
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 | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |