FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 2953193
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00970
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- December 14, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT DEVICES. 5076 IMPLANTABLE PACING LEAD, (B)(6) 2007 BETA BLOCKER, ACE INHIBITOR, WARFARIN, DIURETIC, STATIN, ANTIBIOTIC. (B)(4). NO EVAL EXPLANATION: LEAD WAS NOT RETURNED TO THE MANUFACTURER.
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 HAD RECURRENT (B)(6). TRANSESOPHAGEAL ECHOCARDIOGRAPHY DONE SHOWED ECHODENSITY ON THE RIGHT VENTRICULAR LEAD AS IT TRANSVERSES THE RIGHT ATRIAL LEAD AND 2+ MR WITH A POST LEAFLET VALVE ECHODENSITY. THE SYSTEM WAS EXPLANTED 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 |
|---|---|---|---|---|---|---|---|
| 56980 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |