FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2242669
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06111
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 14, 2011
- 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
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING INAPPROPRIATE SHOCKS. UPON INTERROGATION, THE DEVICE WAS OBSERVED TO BE IN HW RESET MODE. LEAD NOISE WAS ALSO NOTED VIA PSA. FLUOROSCOPY REVEALED LEAD FRACTURE AT THE YOKE OF THE LEAD IN THE RIB-CLAVICLE AREA. THE LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |