FDA Adverse Event
Injury
Summary report: N
UNIFY ASSURA CRT-D
MDR report key: 3872911
·
Received June 13, 2014
Report
- Report Number
- 2938836-2014-11865
- Event Type
- Injury
- Date Received
- June 13, 2014
- Date of Event
- April 21, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A POWER-ON RESET (POR) CAUSED BY LOW BATTERY VOLTAGE. REVIEW OF THE DEVICE IMAGE INDICATED THE LOW BATTERY VOLTAGE WAS NORMAL DUE TO DEVICE USAGE.
Description of Event or Problem · 1
NEW INFORMATION NOTES THAT THE DEVICE WAS EXPLANTED DUE TO BEING IN BACK UP MODE AND REACHING ERI DUE TO HIGH LOW VOLTAGE OUTPUT.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN THE HOSPITAL FOR UNKNOWN REASONS THE DEVICE WAS FOUND TO BE IN BACK UP VVI MODE. FURTHER INVESTIGATION WAS RECOMMENDED. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350015 | UNIFY ASSURA CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3257-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |