FDA Adverse Event
Death
Summary report: N
SPRINT FIDELIS
MDR report key: 3060279
·
Received April 16, 2013
Report
- Report Number
- 2649622-2013-05072
- Event Type
- Death
- Date Received
- April 16, 2013
- Date of Event
- February 11, 2011
- Report Date
- January 30, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE CAUSE OF DEATH IS UNKNOWN. THE PRODUCT IS ON A LEGAL HOLD AND WILL NOT BE ANALYZED. PRODUCT ID: C174AWK, IMPLANTED: (B)(6) 2007; PRODUCT ID: 4574, IMPLANTED: (B)(6) 2007. (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 THE PATIENT IS DECEASED. IT WAS NOTED THERE WAS A "GRADUAL RISING" OF THE HIGH VOLTAGE IMPEDANCE. THERE WAS "NO KNOWN CLINICAL PERFORMANCE ISSUE" AND THE LEAD REMAINED IN USE "BASED ON MEDICAL JUDGMENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162651 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |