FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2242632
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06068
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 2, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THE LEAD WAS RETURNED IN TWO PORTIONS. THE REPORTED NOISE WAS CONFIRMED. INTERNAL ABRASION WAS FOUND AT 10.0-10.7CM, AND 7.0-9.0CM FROM THE DISTAL END. AT 7.0-9.0CM, ONE OF TWO RV CABLES WAS ABRADED. THE ABRADED RV CABLE COULD COME INTO CONTACT WITH THE INNER COIL LEADING TO THE REPORTED NOISE. EXTERNAL ABRASION WAS NOTED BETWEEN 14.3-14.4CM FROM THE DISTAL END CONSISTENT WITH FRICTION TO ANOTHER DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT FREEZE CAPTURES FOUND NOISE. NOISE COULD BE RE-CREATED WITH ARM MOVEMENTS. HIGH VOLTAGE THERAPY WAS TURNED OFF AND LEAD WILL BE MONITORED.
Description of Event or Problem · 1
THE NEW INFORMATION PROVIDED NOTED THAT THE LEAD WAS EXPLANTED.
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 | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |