FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 1955031
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00020
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 7, 2010
- 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 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 PRIOR TO ICD REPLACEMENT, INTERROGATION REVEALED NOISE AND LOW IMPEDANCE. NOISE WAS REPRODUCED BY MOVING THE ICD CAN. LEAD DAMAGE WAS SUSPECTED, BUT THERE WAS NO EVIDENCE UPON EXPLANT. THE NOISE WAS AGAIN REPRODUCED BY STRETCHING THE LEAD. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |