FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 2242749
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06237
- 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
- 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 DURING AN ICD REPLACEMENT PROCEDURE, THE LEADS EXHIBITED HIGH IMPEDANCE AND HIGH CAPTURE THRESHOLDS. HISTORICALLY, MEASUREMENTS HAVE BEEN IN NORMAL RANGES. THE PHYSICIAN SUSPECTED THAT PULLING THE LEADS FROM THE OLD ICD REVEALED AN ACUTE INSULATION TEAR. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7001/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |