BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 3863330 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11033
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 26, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY AS A RESULT OF INCORRECT DETECTION BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE. THE DEVICE INTERPRETED VENTRICULAR TACHYCARDIA (VT) EVEN WHEN THERE WAS NO TRUE MORPHOLOGY CHANGE AND NO SPONTANEOUS ONSET AT THE TIME OF THE DETECTION. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338989 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| L| R 694765 LEAD