FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2083838
·
Received May 10, 2011
Report
- Report Number
- 2017865-2011-03324
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- September 16, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- 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 THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVERSENSING OF NOISE. DURING THE EXPLANT PROCEDURE, THE LEADS TESTED NORMAL AND REMAIN IMPLANTED. DURING THE ICD ANALYSIS, THE STORED EGMS SHOW NOISE SIGNALS CONSISTENT WITH DAMAGED LEAD.
Description of Event or Problem · 1
X-RAY REVEALED INSULATION ANOMALY. THE LEAD WAS CAPPED DURING DEVICE REPLACEMENT.
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 | 56 YR | V-243, (B)(4) AND (B)(4)/52, (B)(4) |