FDA Adverse Event
Injury
Summary report: N
RIATA ST PASSIVE FIXATION
MDR report key: 3220189
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04275
- Event Type
- Injury
- Date Received
- July 11, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
NEW INFORMATION NOTES THE LEAD WAS EXPLANTED AND REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP, DECREASED IMPEDANCE MEASUREMENT WAS OBSERVED. THE PATIENT WILL CONTINUE TO BE MONITORED UNTIL NEXT SCHEDULED FOLLOW-UP VISIT. THE LEAD REMAINS IMPLANTED. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321296 | 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 |