FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
MDR report key: 4760360
·
Received May 8, 2015
Report
- Report Number
- 2938836-2015-04728
- Event Type
- Malfunction
- Date Received
- May 8, 2015
- Date of Event
- March 10, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXHIBITED UNDERSENSING DURING VF EPISODES. THE DEVICE APPROPRIATELY DETERMINED THAT UNDERSENSING WAS OCCURRING AND SUCCESSFULLY TREATED THE VF WITH HIGH VOLTAGE THERAPY. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303667 | QUADRA ASSURA CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3365-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |