BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO II DR

    MDR report key: 2955335 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02076
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 28, 2012
    Report Date
    October 15, 2013
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND REVEALED A CRACKED WELD ON THE BATTERY FILL PORT. CONFIRMED TO BE L EAKING VIA PENETRATING CRACKS IN THE FILLPORT (FP) WELD/BUTTON WELD AREA. THE CRACK MICROSTRUCTURE IS CONSISTENT WITH ENVIRONMENTALLY ASSISTED CRACKING (EAC). NO CONCLUSIVE ROOT CAUSES HAVE BEEN FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT THERAPY: 5076 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WENT TO ELECTIVE REPLACEMENT INDICATOR (ERI) EARLY BATTERY DEPLETION IS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59133 VIRTUOSO II DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD