BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II VR

    MDR report key: 2953111 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01888
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CALLED TO REPORT THAT WHILE THEY WERE SLEEPING THEY WERE AWAKENED BY THEIR DEVICE "VIBRATING." FOLLOW-UP WAS CONDUCTED AND FROM THE INFORMATION OBTAINED IT WAS REPORTED THAT THE PATIENT HAS NOT BEEN SEEN OR CONTACTED THE PHYSICIAN SINCE (B)(6) OF 2012. THE NURSE TRIED TO CALL THE PATIENT BUT WAS UNSUCCESSFUL IN CONTACTING THEM. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55748 MAXIMO II VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D284VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR 693558 IMPLANTABLE TACH LEAD