FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 3151688
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-05666
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- March 26, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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).
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 PACING DEPENDENT PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER HAVING PACING PAUSES. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS REPROGRAMMED AND REMAINS IN USE. ADDITIONAL INFORMATION WAS ATTEMPTED TO BE OBTAINED, HOWEVER, IS NOT AVAILABLE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252231 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00086 YR | Hospitalization| L| R | COMPETITOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |