FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR
MDR report key: 3904223
·
Received July 1, 2014
Report
- Report Number
- 2938836-2014-12761
- Event Type
- Malfunction
- Date Received
- July 1, 2014
- Date of Event
- May 28, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF NO PACING AND LEAD IMPEDANCE ANOMALY WAS CONFIRMED IN THE LABORATORY. VISUAL INSPECTION NOTED THE RING SPRING WAS MISSING FROM THE LV BORE. THE CAUSE OF THE ANOMALY WAS DUE TO THIS MISSING LV RING SPRING.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT, NO PACING AND HIGH, OUT OF RANGE PACING LEAD IMPEDANCE WERE OBSERVED. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 383080 | UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3361-40QC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |