FDA Adverse Event
Injury
Summary report: N
UNIFY CRT-D, DF-4 CONNECTOR
MDR report key: 3880032
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03368
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- November 26, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT RECEIVED INAPPROPRIATE HIGH VOLTAGE AND ANTITACHYCARDIA PACING THERAPY FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE WHEN THE EPISODE WAS ORIGINALLY A SUPRAVENTRICULAR TACHYCARDIA. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25165 | UNIFY CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL INC., CRMD | CD3231-40Q |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR |