FDA Adverse Event
Malfunction
Summary report: N
UNIFY QUADRA CRT-D
MDR report key: 4153561
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16413
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- July 14, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES ANOTHER INSTANCE OF T-WAVE OVERSENSING. NO FURTHER ACTION WAS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DEVICE INTERROGATION REVEALED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS NOT AWARE OF ANY ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631894 | UNIFY QUADRA CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3249-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |