FDA Adverse Event
Death
Summary report: N
SPRINT FIDELIS
MDR report key: 4243647
·
Received November 11, 2014
Report
- Report Number
- 2649622-2014-13011
- Event Type
- Death
- Date Received
- November 11, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 25, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Removal / Correction Number
- Z-0070-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. CONCOMITANT: PRODUCT ID 4076 LEAD, IMPLANTED: 2007-(B)(6); 4193 LEAD, IMPLANTED 2007-(B)(6), (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE. DURING THE LASER LEAD EXTRACTION THE PATIENT DIED DUE TO A TEAR FROM THE INNOMINATE VEIN TO THE RIGHT ATRIUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727877 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Death | D274TRK ICD |