FDA Adverse Event
Malfunction
Summary report: N
UNIFY CRT-D
MDR report key: 3880393
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03529
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- February 23, 2011
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, 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 REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN HV LEAD IMPEDANCE ALERT WAS DISPLAYED ON A MERLIN.NET TRANSMISSION. REVIEW OF THE SESSION RECORDS SHOWED NO HV LEAD IMPEDANCE ISSUES ON THE DAILY OR MONTHLY TRENDS. SESSION RECORDS HAVE BEEN SUBMITTED FOR FURTHER REVIEW VIA ENGINEERING DEPARTMENT. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27128 | UNIFY CRT-D | IMPLANTABLE CARDIOVERTER DEFRIBILLATOR, NIK | NIK | ST. JUDE MEDICAL, INC. CRMD | CD3231-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |