FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
MDR report key: 3943949
·
Received July 18, 2014
Report
- Report Number
- 2938836-2014-13368
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 4, 2014
- 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
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, INHIBITION OF PACING DUE TO MYOPOTENTIAL OVERSENSING WAS OBSERVED. PATIENT IS NOT DEPENDENT. PROGRAMMING CHANGES WERE MADE. THE FOLLOWING DAY, THE OVERSENSING CONTINUED AND ADDITIONAL PROGRAMMING CHANGES WERE MADE. PATIENT WILL CONTINUE TO BE MONITORED CLOSELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423196 | 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 | 78 YR |