FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D, DF4 CONNECTOR
MDR report key: 3220360
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04634
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 7, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT ALTHOUGH REPROGRAMMING WAS PERFORMED, THE ISSUE OF INTERMITTENT UNDERSENSING WAS STILL OBSERVED. FURTHER PROGRAMMING CHANGES WERE RECOMMENDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT VIA A MERLIN.NET TRANSMISSION, INTERMITTENT UNDERSENSING AND OVERSENSING DUE TO MYOPOTENTIALS WAS NOTICED ON THE DISCRIMINATION CHANNEL. NO THERAPIES WERE INHIBITED OR DELIVERED TO THE PATIENT. THE DEVICE WILL BE TESTED FOR NOISE. THE PATIENT WILL BE MONITORED.
Description of Event or Problem · 1
NEW INFORMATION NOTES THE DEVICE WAS REPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320502 | QUADRA ASSURA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3265-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |