FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2973396
·
Received February 21, 2013
Report
- Report Number
- 2938836-2013-00163
- Event Type
- Injury
- Date Received
- February 21, 2013
- Date of Event
- January 21, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- 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 THE LEAD HAD EXTERNALIZED CONDUCTORS. THE DECISION WAS MADE TO CAP AND REPLACE THE LEAD. IT WAS NOTED THAT THE LEAD HAD PREVIOUS ELECTRICAL PROBLEMS AND THE SENSE PACE PORTION OF THE LEAD WAS CAPPED BACK IN 2006.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED FROM AN ATTORNEY NOTES THAT THE PATIENT ALSO RECEIVED INAPPROPRIATE THERAPIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76599 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |