FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 2955505
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-01390
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- December 5, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. CONCOMITANT PRODUCT : 5076 IMPLANTABLE PACING LEAD (B)(6) 2002. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WHEN A LEAD INTEGRITY ALERT WAS TRIGGERED. THE RIGHT VENTRICULAR LEAD WAS OVERSENSING AND HAD HIGH IMPEDANCE; A FRACTURE WAS SUSPECTED. THE LEAD WAS INACTIVATED 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 |
|---|---|---|---|---|---|---|---|
| 59152 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | Hospitalization| R | D284DRG IMPLANTABLE DEFIBRILLATOR |