FDA Adverse Event
Malfunction
Summary report: N
FORTIFY ASSURA DR ICD, US
MDR report key: 6970866
·
Received October 24, 2017
Report
- Report Number
- 2017865-2017-33523
- Event Type
- Malfunction
- Date Received
- October 24, 2017
- Date of Event
- September 21, 2017
- Report Date
- October 23, 2017
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- LWS
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC. LOSS OF CAPTURE WAS NOTED ON THE ATRIAL LEAD. THE DEVICE HAD MULTIPLE NON SUSTAINED OVERSENSING EPISODES (NSO) AND WAS OVERSENSING SIGNALS THAT APPEARED TO BE MYOPOTENTIALS ON THE VENTRICULAR CHANNEL. ATRIAL LEAD OUTPUT WAS INCREASED. PROGRAMMING CHANGES WERE DONE TO ADDRESS NSO AND THE ISSUE WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 752655 | FORTIFY ASSURA DR ICD, US | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | CD2357-40Q | A000016552 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |