FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 2953529
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-01193
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- November 7, 2012
- Report Date
- November 7, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, 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 PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. IT WAS ALSO NOTED THAT THE ALERT FOR HIGH RV PACING IMPEDANCE WAS TRIGGERED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56720 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6947 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Hospitalization| R | D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB |