FDA Adverse Event
Malfunction
Summary report: N
PROMOTE RF
MDR report key: 1073491
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02270
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- April 7, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- MD
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPIES. DURING FOLLOW-UP, A MAGNET WAS PLACED OVER THE DEVICE TO INHIBIT THERAPIES; HOWEVER, DELIVERY CONTINUED EVEN AFTER REPOSITIONING OF THE MAGNET. THE DEVICE WAS INTERROGATED AND SEVERAL EPISODES WERE NOTED. WHILE ATTEMPTING TO PROGRAM TACHY THERAPIES OFF, THE PROGRAMMER FROZE. THE PROGRAMMER WAS REBOOTED AND THE EGMS WERE NO LONGER AVAILABLE. THERAPIES WERE PROGRAMMED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROMOTE RF | IMPLANTIBLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 3207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |