FDA Adverse Event
Malfunction
Summary report: N
FORTIFY DR
MDR report key: 4092058
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-05088
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- January 3, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. F12: UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT INTERMITTENT OUT OF RANGE HIGH ON RIGHT VENTRICULAR PACING LEAD IMPEDANCE WAS OBSERVED. DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22651 | FORTIFY DR | IMPLANTABLE CARDIOVERTER DIFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC. CRMD | CD2231-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |