FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 3152984
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05764
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 12, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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. CONCOMITANT PRODUCT: D234VRC, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2010. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD WAS OBSERVED WITH ELEVATED THRESHOLD AND HIGH IMPEDANCE. THE LEAD WAS EXPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256212 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6944-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00035 YR | Hospitalization| R |