BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II VR

    MDR report key: 2811217 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06171
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    Z-0114-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED LOW RESISTANCE DUE TO A SHORT IN THE INTEGRATED CIRCUIT. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED AT ALL ON ROUTINE VISIT. THIS WAS DESPITE TRYING MULTIPLE PROGRAMMERS TO CONNECT. IT WAS PRESUMED TO BE AT EOL (END OF LIFE) AND COMPLETELY DEAD. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED AT ALL ON ROUTINE VISIT. THIS WAS DESPITE TRYING MULTIPLE PROGRAMMERS TO CONNECT. IT WAS PRESUMED TO BE AT EOL (END OF LIFE) AND COMPLETELY DEAD. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D284VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD