BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 1072286 · Received July 10, 2008

    Report

    Report Number
    6000144-2008-00145
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 22, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: NO ANOMALIES WERE FOUND. IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVERSENSING, AND HV IMPEDANCE READINGS WERE GREATER THAN 200 OHMS. THE DEVICE WAS EXPLANTED. DURING THE EXPLANT PROCEDURE, IT WAS NOTED THAT THE HVB PIN WAS DISLODGED FROM THE PORT, WAS 'LOOSE', AND WAS NOT IN CONTACT WITHIN THE PORT. TISSUE AND FLUID WERE ALSO FOUND IN THE LEAD PORT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED MECHANICAL TESTS PERFORMED VISUAL EXAMINATION DEVICE PERFORMED ACCORDING TO SPECIFICATIONS DEVICE OPERATED ACCORDING TO SPECIFICATIONS IMPEDANCE, HIGH OVERSENSING SHOCK, INAPPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVERSENSING, AND HV IMPEDANCE READINGS WERE GREATER THAN 200 OHMS. THE DEVICE WAS EXPLANTED. DURING THE EXPLANT PROCEDURE, IT WAS NOTED THAT THE HVB PIN WAS DISLODGED FROM THE PORT, WAS 'LOOSE', AND WAS NOT IN CONTACT WITHIN THE PORT. TISSUE AND FLUID WERE ALSO FOUND IN THE LEAD PORT. 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 MAXIMO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7232CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6949 IMPLANTABLE TACHY LEAD