FDA Adverse Event
Injury
Summary report: N
PHOTON MICRO VR
MDR report key: 1223405
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03659
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 17, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED THE HWVVI WAS CONFIRMED. ANALYSIS OF THE RAM MAP REVEALED THAT THE DEVICE RESET WHILE DELIVERING HIGH VOLTAGE THERAPY. AN EGM RECORDED ON RESET DATE, SHOWED A SLIGHT NOISE ON THE RV TO ICD CAN CHANNEL. AN AUTOMATED ELETRICAL SYSTEM TEST WAS PERFORMED. THE DEVICE PASSED ALL TESTS AND NO ANOMALIES WERE DETECTED. ALL CURRENT AND POWER CONSUMPTION MEASUREMENTS WERE NORMAL. IT IS BELIEVED THAT THE DEVICE ENTERED HWVVI RESET MODE AFTER DELIVERING HV THERAPY INTO A DAMAGED LEAD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED A VT. DURING INTERROGATION OF THE DEVICE, AN ERROR MESSAGE OF BACKUP VVI WAS OBSERVED. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHOTON MICRO VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-194 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |