FDA Adverse Event
Death
Summary report: N
SPRINT FIDELIS
MDR report key: 3832750
·
Received May 27, 2014
Report
- Report Number
- 2649622-2014-04861
- Event Type
- Death
- Date Received
- May 27, 2014
- Date of Event
- March 25, 2007
- Report Date
- April 28, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT'S FAMILY THAT THE PATIENT IS DECEASED. PER THE PATIENT'S DAUGHTER, THE PATIENT "NEVER LEFT THE HOSPITAL" AND THE PHYSICIAN COULD NOT EXPLAIN WHY THE PATIENT "WAS SICK AND HAVING PROBLEMS AFTER THE SURGERY". THE PATIENT IS REPORTED TO HAVE DIED DUE TO HEART FAILURE AND THE "THE DEVICE DIDN'T SHOCK". PER THE PATIENT'S SPOUSE, THE DEATH WAS DUE TO A "BAD LEAD WIRE". FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY FOUR MONTHS AFTER LEAD IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310759 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC PUERTO RICO OPERATIONS CO. | 6949 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00082 YR | Death | V365 ICD, 4548 LEAD, 1688T LEAD |