FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO
MDR report key: 2965082
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-02034
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Report Date
- December 19, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD ELEVATED THRESHOLD. THEREFORE PROGRAMMING CHANGES WERE MADE AND THE RV LEAD REMAINS IN USE. IT WAS NOTED THAT THE PATIENT IS PART OF THE UATP 2.0 STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67353 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Required Intervention | D274DRG IMPLANTABLE PACEMAKER CARDIO/DEFIB |