FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR, DF-4 CONNECTOR
MDR report key: 4760304
·
Received May 8, 2015
Report
- Report Number
- 2938836-2015-04717
- Event Type
- Malfunction
- Date Received
- May 8, 2015
- Date of Event
- March 14, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A REGULARLY SCHEDULED VISIT AND EPISODES OF OVERSENSING WERE FOUND. CHARGING WAS ASSOCIATED WITH ALL OF THE NON-SUSTAINED VENTRICULAR OVERSENSING EPISODES. REVIEW OF THE EPIOSDES SHOWED THAT THE DEVICE WAS PERFORMING A HIGH VOLTAGE CIRCUITRY CHECK CAUSING T-WAVE OVERSENSING WHICH ABORTED THE CHECK. PROGRAMMING CHANGES WERE PLANNED FOR PATIENTS NEXT SCHEDULED FOLLOW-UP.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT PROGRAMMING CHANGES WERE MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 305199 | FORTIFY ASSURA DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2259-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |