FDA Adverse Event
Malfunction
Summary report: N
UNIFY CRT-D
MDR report key: 3943917
·
Received July 18, 2014
Report
- Report Number
- 2938836-2014-13394
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 13, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORTER: CLINIC PERSONNEL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED A TRANSMISSION FOR BACK UP VVI VIA MERLIN.NET. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THE BACKUP VVI TRANSMISSION WAS INAPPROPRIATE. THE DEVICE WAS NOT FOUND IN BACK UP VVI. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421855 | UNIFY CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3235-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |