FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 2955510
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-01459
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- December 14, 2012
- Report Date
- December 14, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
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 FOR SHORT V-V INTERVALS. THERE WAS NOISE INTERFERENCE ON THE PACE/SENSE PORTION. THE PACE/SENSE PORTION WAS CAPPED AND WAS REPLACED. THE RV 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 |
|---|---|---|---|---|---|---|---|
| 58596 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |