FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
MDR report key: 3101263
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-02058
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- March 6, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN-CLINIC FOR FOLLOW-UP WITH A DEVICE THAT WAS POST-PACED T-WAVE OVERSENSING. THE PATIENT DID NOT RECEIVE THERAPY. IT WAS RECOMMENDED TO REPROGRAM THE DEVICE.
Description of Event or Problem · 1
NEW INFORMATION INDICATED THE DEVICE WAS REPROGRAMMED IN THE PAST BUT POST-PACED T-WAVE OVERSENSING ISSUE REMAINED. FURTHER PROGRAMMING CHANGES WERE RECOMMENDED.
Description of Event or Problem · 1
NEW INFORMATION INDICATED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204248 | QUADRA ASSURA CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3265-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |