FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECUR
MDR report key: 2952144
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00434
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Report Date
- November 15, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015/S024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- 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).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT. THE LEAD SHOWED UNSTABLE IMPEDANCE VALUES, SEVERAL SHORT V-V INTERVALS, AND NON-PHYSIOLOGICAL NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT). THE BEGINNING OF A POSSIBLE LEAD FRACTURE WAS SUSPECTED. THE LEAD REMAINS IN USE WITH CLOSE MONITORING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57364 | SPRINT QUATTRO SECUR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00084 YR |