FDA Adverse Event
Injury
Summary report: N
RIATA ST PASSIVE FIXATION LEAD
MDR report key: 1073081
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02327
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 7, 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 A PARTIAL LEAD CUT IN TWO PIECES WERE RETURNED FOR ANALYSIS. WITHOUT THE ENTIRE LEAD, A COMPLETE EVALUATION CANNOT BE PERFORMED. THE ELECTRICAL CHARACTERISTICS OF THE RETURNED PORTION EXHIBITED NORMAL COIL CONTINUITY. NO ANOMALIES WERE FOUND ON ANY OF THE RETURNED PORTIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN INCREASE IN IMPEDANCE AND AN INCREASE IN CAPTURE WERE OBSERVED. THE LEAD WAS EXPLANTED AFTER THREE DAYS OF IMPLANT, REQUIRING EXTRA SURGERY AND EXTENDING THE HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST PASSIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7041/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |