FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 3801283
·
Received May 8, 2014
Report
- Report Number
- 2938836-2014-10940
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Date of Event
- March 11, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED WHEN THE PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW UP, LEAD NOISE WAS OBSERVED. INCREASED IN THRESHOLD WAS ALSO NOTED. PERFORMING LEAD TESTING WAS SUGGESTED. THE HV THERAPY WAS DISABLED. THE LEAD WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278776 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7001/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |