FDA Adverse Event
Injury
Summary report: N
UNIFY QUADRA CRT-D, DF-4 CONNECTOR
MDR report key: 4133721
·
Received October 1, 2014
Report
- Report Number
- 2938836-2014-16278
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- August 19, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT PRESENTED IN THE ER AFTER RECEIVING INAPPROPRIATE ANTITACHYCARDIA PACING AND SHOCK THERAPY. PROGRAMMING CHANGES WERE MADE; NO FURTHER ISSUES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610895 | UNIFY QUADRA CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3249-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |