FDA Adverse Event
Injury
Summary report: N
CURRENT RF DR
MDR report key: 1050651
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01613
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- February 13, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
PATIENT PRESENTED TO CLINIC FOR A FOLLOW-UP. INITIAL DEVICE INTERROGATION WAS SUCCESSFUL AND ALL PARAMETERS WERE WITHIN ACCEPTABLE VALUES. UPON EGM REVIEW, A POP UP MESSAGE APPEARED STATING THAT THE DEVICE WAS IN HARDWARE BACKUP. THE PROGRAMMER WAS REBOOTED AND THE DEVICE WAS REINTERROGATED, BUT THE SAME MESSAGE APPEARED. HENCE, THE DEVICE WAS EXPLANTED WITH NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT RF DR | NO BNCN FOUND FOR THIS DEVICE | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |