FDA Adverse Event
Malfunction
Summary report: N
SPRINT
MDR report key: 3160444
·
Received June 10, 2013
Report
- Report Number
- 2649622-2013-07976
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Report Date
- March 26, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA). THE ALERT WAS BASED ON HIGH SHORT INTERVAL COUNTS (SIC) AND FAST NON SUSTAINED VENTRICULAR INTERVALS. THE PATIENT HAD SEVERAL NON SUSTAINED VENTRICULAR TACHYCARDIA (VT)SHOWING NOISE ON THE RV EGM CHANNEL. IT IS SUSPECTED THAT THE NOISE ARTIFACTS ON THE RV LEAD SIGNAL ARE FROM ELECTROMAGNETIC INTERFERENCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259514 | SPRINT | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6942-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | D234DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |