FDA Adverse Event
Malfunction
Summary report: N
UNIFY CRT-D, DF-4 CONNECTOR
MDR report key: 4030775
·
Received August 22, 2014
Report
- Report Number
- 2938836-2014-14601
- Event Type
- Malfunction
- Date Received
- August 22, 2014
- Date of Event
- July 2, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED FOR FOLLOW-UP, MULTIPLE EPISODES OF INAPPROPRIATE AUTO MODE SWITCH DUE TO ATRIAL NOISE WERE OBSERVED. THE DEVICE REMAINS IMPLANTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509707 | UNIFY CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3235-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |