FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D
MDR report key: 4021815
·
Received August 19, 2014
Report
- Report Number
- 2938836-2014-14491
- Event Type
- Malfunction
- Date Received
- August 19, 2014
- Date of Event
- June 17, 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
- IL, US
- Reporter Occupation
- OTHER
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 THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. THE DEVICE WAS POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL, WHICH WAS NOTED ON A STORED EGM. THE ICD WAS REPROGRAMMED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT FURTHER EPISODES OF POST-PACED T-WAVE OVERSENSING WERE OBSERVED. REPROGRAMMING WAS RECOMMENDED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED INDICATED THAT PATIENT PRESENTED TO THE CLINIC FOR FOLLOW-UP WITH DEVICE EXHIBITING ANOTHER INSTANCE OF POST-PACED T-WAVE OVERSENSING AFTER PROGRAMMING CHANGES WERE MADE. FURTHER PROGRAMMING CHANGES WERE RECOMMENDED AND WILL BE MADE WHEN PATIENT RETURNS TO THE CLINIC IN A FEW MONTHS FOR FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 498399 | QUADRA ASSURA CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3265-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |