BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 3071776 · Received April 22, 2013

    Report

    Report Number
    9614453-2013-01030
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0598-05
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 95% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SHOCKED BY THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT IS ENROLLED IN THE SYSTEM LONGEVITY STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FURTHER INFORMATION FROM THE SITE INDICATES THAT THE SHOCK WAS APPROPRIATE DUE TO AN EPISODE OF FAST VENTRICULAR TACHYCARDIA (VT). THE SETTINGS WERE ADJUSTED AND THE DEVICE WAS SUBSEQUENTLY UPGRADED TO A BIVENTRICULAR DEFIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172198 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC S.A. (SMO) 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| L| R 6942 IMPLANTABLE TACHY LEAD