BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 2122921 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02238
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    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 DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT WHILE ON VACATION, HER DEVICE ALARM "BEGAN TO SOUND." THE PATIENT REPORTED THAT THE PHYSICIAN BELIEVED IT WAS THE BATTERIES "GOING OUT." ON A FOLLOW UP VISIT A MONTH LATER, IT WAS DISCOVERED THAT THE LEAD WIRES HAD "CORRODED THROUGH AND DISCONNECTED." DURING THE EXTRACTION PROCEDURE, THE PHYSICIAN REMOVED AS MUCH OF THE LEAD AS POSSIBLE. THE PATIENT INDICATED THAT THE "DEFECTIVE" DEVICE WAS ALSO REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE 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 70 YR Hospitalization| R