FDA Adverse Event
Death
Summary report: N
FORTIFY ASSURA DR ICD, US
MDR report key: 6098289
·
Received November 13, 2016
Report
- Report Number
- 2938836-2016-14096
- Event Type
- Death
- Date Received
- November 13, 2016
- Date of Event
- October 15, 2016
- Report Date
- September 25, 2017
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THE DEVICE WAS TESTED ON THE BENCH USING AUTOMATED TESTING EQUIPMENT, AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 749379 | FORTIFY ASSURA DR ICD, US | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2357-40C | 4778644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death | (B)(4)| (B)(4) |