BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2953464 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00243
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 10, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED THROUGH FOLLOW UP REVEALED FROM THE CLINIC THAT THE PATIENT WAS NOT COMPLIANT AND WOULD DO THINGS SUCH AS TAPE A MAGNET OVER THE DEVICE SO THE PATIENT COULD USE CHAIN SAWS AND RUN MARATHONS. THE CLINIC IS UNSURE IF HE WILL ACTUALLY GO AND HAVE THE DEVICE REMOVED AS THEY HAVE A HARD TIME CONTACTING THIS PATIENT. THE SAVE TO DISK OF THE DEVICE WAS REVIEWED. IT REVEALED THE TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN SAVE TO DISK IS (B)(6) 2012, DEVICE RRT LESS THAN OR EQUAL TO 2.6251 VOLT. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS A MINIMUM BATTERY EQUAL TO2.635 TO 2.582 VOLTS BETWEEN (B)(6) 2012. IN ADDITION THERE WAS ONE LOW BATTERY VOLTAGE ALERT ON (B)(6) 2012. OVERSENSING WAS OBSERVED WITH FIVE HIGH RATES LESS THAN OR EQUAL TO 217 MS AVERAGE V-CYCLE ON (B)(6) 2012. THERE WAS ONE VENTRICULAR FIBRILLATION (VF) EPISODE ON (B)(6) 2011. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE U.S., HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE PAST THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FOR RAPIDLY CONDUCTED ATRIAL FIBRILLATION. THE PATIENT CAME INTO THE CLINIC REPORTING THAT THEIR DEVICE HAD BEEN BEEPING FOR A WHILE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED. THE DEVICE CURRENTLY REMAINS IN USE BUT THE PATIENT HAS REQUESTED THE DEVICE BE EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57063 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R