FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR ICD, US
MDR report key: 8220368
·
Received January 4, 2019
Report
- Report Number
- 2017865-2019-00280
- Event Type
- Malfunction
- Date Received
- January 4, 2019
- Date of Event
- December 21, 2018
- Report Date
- January 24, 2019
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVZ
- UDI-DI
- 05414734508094
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTED THAT THE RECOMMENDED PROGRAMMING CHANGES WERE MADE AND NO FURTHER ISSUES WERE SEEN BY THE CLINIC.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH MULTIPLE EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING. THE EPISODES WERE DUE TO PROGRAMMED LENGTHENED PAV DELAY CAUSING COMPETITIVE VENTRICULAR PACING AND SUBSEQUENT OVERSENSING. ALTERNATIVE PROGRAMMING WAS RECOMMENDED. THE PATIENT WAS IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9534 | FORTIFY ASSURA DR ICD, US | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NVZ | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | CD2357-40Q | A000062998 | 05414734508094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |