FDA Adverse Event
Injury
Summary report: N
RIATA ST PASSIVE FIXATION
MDR report key: 1223481
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03631
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- July 28, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
DURING A FOLLOW UP, THE PHYSICIAN NOTED AN INCREASE IN THRESHOLD. IT WAS OBSERVED THAT THE LEAD HAD PERFORATED. PHYSICIAN ELECTED TO EXPLANT THE LEAD, AND WAS REPLACE WITH NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST PASSIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7040/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |