FDA Adverse Event
Injury
Summary report: N
PROMOTE QUADRA CRT-D, DF-4 CONNECTOR
MDR report key: 3911051
·
Received July 2, 2014
Report
- Report Number
- 2938836-2014-12989
- Event Type
- Injury
- Date Received
- July 2, 2014
- Date of Event
- May 13, 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 BACKUP DFO WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALY WAS FOUND. THE CAUSE OF THE RESET COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW UP THE DEVICE COULD NOT BE INTERROGATED. A VIBRATORY ALERT WAS THEN DELIVERED DURING INTERROGATION AND BACKUP VVI WAS NOTED. THE DEVICE WAS EXPLANTED. THE PATIENT WAS FINE AFTER EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385925 | PROMOTE QUADRA CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3239-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |