FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 3153249
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05891
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- April 24, 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 INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. D11 CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2005-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS T WAVE OVERSENSING. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256070 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR | Hospitalization| L| R | 7278 IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR |