FDA Adverse Event
Death
Summary report: N
QUADRA ASSURA DDQP+
MDR report key: 6144109
·
Received December 4, 2016
Report
- Report Number
- 2938836-2016-15306
- Event Type
- Death
- Date Received
- December 4, 2016
- Date of Event
- November 24, 2016
- Report Date
- November 25, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT PRESENTED WITH VENTRICULAR FIBRILLATION AND WAS TREATED WITH AN EXTERNAL DEFIBRILLATOR AND INTUBATION. UPON INTERROGATION OF THE DEVICE, NO EPISODES OR THERAPIES WERE RECORDED. ALL ELECTRICAL PARAMETERS WERE WITHIN NORMAL RANGE. REVIEW OF THE SESSION RECORDS REVEALED THE CRITERIA FOR VT/VF DETECTION CRITERIA MAY HAVE NOT BEEN FULFILLED DUE TO THE PROGRAMMED DEVICE PARAMETERS. THE PATIENT EXPIRED TWO DAYS LATER. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 794657 | QUADRA ASSURA DDQP+ | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC. | CD3267-40Q | 3957984 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |