FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3101064
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-01852
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- March 5, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS OBSERVED. UPON EVALUATION THE PHYSICIAN DECIDED THAT THE PATIENT NO LONGER REQUIRED ICD SUPPORT. THE LEAD WAS CAPPED AND AN OLD ABANDONED LEAD WAS RECONNECTED FOR PACE/SENSE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT SUFFERED FROM INAPPROPRIATE THERAPIES PRIOR TO LEAD REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204226 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1590/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |