FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2242852
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06167
- Event Type
- Malfunction
- Date Received
- September 11, 2011
- Date of Event
- June 22, 2011
- 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 NOISE WAS OBSERVED ON THE VENTRICULAR LEAD. THE PHYSICIAN SUSPECTED EXTERNAL INTERFERENCE BUT REVIEW OF THE EPISODES SHOWED THAT THE COMPETITOR ATRIAL LEAD ALSO HAD NOISE. IT WAS ADVISED THAT THE PATIENT BE BROUGHT BACK TO THE CLINIC FOR FOLLOW UP.
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 | 1582/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MEDTRONIC LEAD |