FDA Adverse Event
Malfunction
Summary report: N
UNIFY ASSURA CRT-D
MDR report key: 4153546
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16308
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- April 19, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
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 AN ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC WITH AN EPISODE OF NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING. THE OVERSENSING WAS NOTED IN THE STORED EGM. THE DEVICE WAS REPROGRAMMED. THE PATIENT CONDITION WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631838 | UNIFY ASSURA CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3257-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |