FDA Adverse Event
Malfunction
Summary report: N
FORTIFY DR, DF4 CONNECTOR
MDR report key: 4091543
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-04856
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- July 12, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS REC'D. 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 PRIOR TO IMPLANT, WHILE STILL IN STERILE PACKAGE, THE DEVICE WOULD NOT INTERROGATE OR COMMUNICATE WITH THE PROGRAMMER. THIS DEVICE WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23263 | FORTIFY DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL INC., CRMD | CD2231-40Q |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |