FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3210666
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03239
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- May 6, 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
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT DAMAGE (DEVICES).
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC FOR A FOLLOW UP. EXTERNALIZED CONDUCTORS WERE NOTED VIA FLUOROSCOPY. NO ELECTRICAL ANOMALIES WERE NOTED. THE LEAD WILL BE EXPLANTED AND REPLACED.NEW INFORMATION NOTES THE LEAD WAS EXPLANTED AND WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC FOR A FOLLOW UP. EXTERNALIZED CONDUCTORS WERE NOTED VIA FLUOROSCOPY. NO ELECTRICAL ANOMALIES WERE NOTED. THE LEAD WILL BE EXPLANTED AND REPLACED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THE LEAD REMAINS ACTIVE AND WAS NOT EXPLANTED AS PREVIOUSLY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309703 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |