FDA Adverse Event
Malfunction
Summary report: N
UNIFY CRT-D
MDR report key: 4130741
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16250
- Event Type
- Malfunction
- Date Received
- September 30, 2014
- Date of Event
- September 10, 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 Location
- IT
- 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 DEVICE INTERROGATION REVEALED AUTO MODE SWITCH EPISODES. THE PHYSICIAN SUSPECTED THE EPISODES WERE INAPPROPRIATE DUE TO EXTERNAL INTERFERENCE. THE PHYSICIAN ELECTED TO TAKE NO ACTION. THE PATIENT MEDICAL CONDITION WAS GOOD BEFORE AND AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607991 | UNIFY CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3235-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |