FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2242662
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06091
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 3, 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
- GA
- 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
ANALYSIS FOUND EXTERNAL INSULATION ABRASIONS AT 50.3CM TO 50.5CM, CONSISTENT WITH THAT PRODUCED BY FRICTION WITH THE ICD CAN AND 10.5CM TO 11.7CM, CONSISTENT WITH THAT PRODUCED BY FRICTION WITH ANOTHER DEVICE FROM DISTAL TIP.
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH IMPEDANCE WAS OBSERVED. LEAD DAMAGE WAS SUSPECTED, ALTHOUGH, NO APPARENT DAMAGE ON THE LEAD BODY WAS OBSERVED UPON REMOVAL.
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 | 59 YR | Required Intervention |