BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM VR

    MDR report key: 2791450 · Received October 15, 2012

    Report

    Report Number
    2647346-2012-01708
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061/S35
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED BATTERY VOLTAGE - POWER ON RESET PARAMETERS. THE TRANSLATED TEXT SAVE TO DISK FILE (B)(4) WITH PORS SHOWS THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) <=2.55 VOLT, AND DEVICE REACHED END OF LIFE (EOL) <= 2.40 VOLT ON OR BEFORE (B)(4) 2012. S2D DATA SHOWS BATTERY VOLTAGE = 2.00 VOLT ON (B)(4) 2012, POWER ON RESET - (POR) POWER ON RESET PARAMETERS, 4 - PORS FOR VREG MONITOR (MICRO SUPPLY) ON (B)(4) 2012, IN THE TIMEFRAME BETWEEN 11:58:11 AND 11:58:14, AND 1 - PATIENT ALERT FOR POR ON (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING A SHOCK. IT WAS ALSO REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET WITH A BATTERY VOLTAGE OF 2.0V AND WAS AT END OF LIFE (EOL). THE DEVICE COUNTERS WERE RESET AND WHEN THE DEVICE WAS INTERROGATED ALL THE DATA WAS LOST DUE TO EOL. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD WENT TO THE ER (EMERGENCY ROOM) AS SHE STATED THAT SHE RECEIVED ANOTHER SHOCK FROM THE DEVICE. THE DEVICE WAS INTERROGATED AND BATTERY VOLTAGE WAS 1.95V; IT WAS NOTED THAT THIS DEVICE IS KNOWN TO BE AT EOL (END OF LIFE) SINCE (B)(6) 2012. ALL DETECTIONS ARE OFF. THE DEVICE WAS EXPLANTED AND REPLACE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL, INC. 7227CX

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R 6944 IMPLANTABLE TACHY LEAD