FDA Adverse Event
Injury
Summary report: N
QUADRA ASSURA DR CRT-D
MDR report key: 3801272
·
Received May 8, 2014
Report
- Report Number
- 2938836-2014-10993
- Event Type
- Injury
- Date Received
- May 8, 2014
- Date of Event
- February 25, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED TO THE CLINIC, THE DEVICE WAS POST-PACED T-WAVE OVERSENSING. THE ASYMPTOMATIC PATIENT RECEIVED INAPPROPRIATE ATP AND HIGH VOLTAGE THERAPY. A REMOTE TRANSMISSION SHOWED NON-SUSTAINED LEAD NOISE DUE TO MYOPOTENTIAL OVERSENSING. THE DEVICE WAS REPROGRAMMED. ANOTHER ALERT WAS RECEIVED LATER. HOWEVER, NO FURTHER PROGRAMMING CHANGES WERE MADE SINCE NO FURTHER LEAD NOISE WAS OBSERVED. IMPEDANCE FLUCTUATIONS WERE ALSO NOTED, BUT RETURNED TO NORMAL WHEN MEASURED IN-CLINIC. THE PATIENT IS STABLE AND WILL CONTINUE TO BE REMOTELY MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279525 | QUADRA ASSURA DR CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3365-40C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |