FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D DF4 CONNECTOR
MDR report key: 2984527
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00584
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 7, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED EXTENDED CHARGE TIME ANOMALY WAS CONFIRMED IN THE LABORATORY. ANALYSIS OF THE DEVICE IDENTIFIED AN ANOMALOUS COMPONENT WITHIN THE HYBRID CIRCUITRY. THIS WOULD ACCOUNT FOR THE HIGH VOLTAGE CHARGE TIMES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALERT AND PRESENTED FOR PHYSICIAN VISIT. EXTENDED CHARGE TIME WAS NOTED AND CAPACITOR MAINTENANCE COULD NOT BE PERFORMED. TELEMETRY WAS LOST DURING THE ATTEMPT AND HEARD A NOISE COMING FROM THE DEVICE. DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88298 | QUADRA ASSURA CRT-D DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3267-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |