FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 2952330
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00503
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- November 17, 2012
- Report Date
- November 17, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015/S029
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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).
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 PATIENT WENT TO THE EMERGENCY ROOM DUE TO INAPPROPRIATE SHOCKS AS A RESULT OF T-WAVE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE SENSITIVITY WAS REPROGRAMMED AND THE LEAD REMAINS IN USE. THE PHYSICIAN NOTED THAT THE PATIENT HAD A MEDICATION CHANGE APPROXIMATELY ONE MONTH BEFORE THIS OCCURRENCE WHICH RESULTED IN A STATE OF DEHYDRATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS THE RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56922 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | Hospitalization| L| R | D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |