FDA Adverse Event
Injury
Summary report: N
QUADRA ASSURA DR CRT-D, DF-4 CONNECTOR
MDR report key: 3914586
·
Received July 3, 2014
Report
- Report Number
- 2938836-2014-13124
- Event Type
- Injury
- Date Received
- July 3, 2014
- Date of Event
- May 5, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF AN INABILITY TO COMMUNICATE WITH THE DEVICE WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND AN ANOMALY WAS NOTED ON THE TELEMETRY COIL. THE ROOT CAUSE OF THE FIELD EVENT WAS DUE TO AN ANOMALOUS SOLDER JOINT ON THE COIL WIRING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED DURING A ROUTINE FOLLOW-UP. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS FINE FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389872 | QUADRA ASSURA DR CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3367-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |