FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 2951634
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00152
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- December 5, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015/S029
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 SUPERIOR VENA CAVA (SVC) PORTION OF THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A RISE IN IMPEDANCES. THE SVC COIL WAS PROGRAMMED OFF, AND DEFIBRILLATION THRESHOLD TESTS WERE PERFORMED SUCCESSFULLY. THE PHYSICIAN EXPRESSED FRUSTRATION WITH THE LEAD IN GENERAL. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55744 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Hospitalization| R | (B)(4) IMPLANTABLE DEFIBRILLATOR |