FDA Adverse Event
Injury
Summary report: N
PROMOTE RF
MDR report key: 1073066
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02311
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 14, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 DEVICE WAS OBSERVED TO BE IN BACKUP VVI MODE. THE PATIENT WAS HAVING MRI SCAN DONE AND FELT SYMPTOMATIC. PATIENT NOTICED A HIGHER OUTPUT JUST AFTER THE MRI SCAN BEGAN. TECHNICAL SERVICES WORKED WITH FIRMWARE ENGINEERING TO ATTEMPT TO RECOVER THE DEVICE, HOWEVER, IT WAS UNSUCCESSFUL. AS SUCH, THE DEVICE WAS EXPLANTED.
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 | Required Intervention |