BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPACT DELTA II

    MDR report key: 7962514 · Received October 12, 2018

    Report

    Report Number
    1037955-2018-00066
    Event Type
    Death
    Date Received
    October 12, 2018
    Date of Event
    March 13, 2018
    Report Date
    September 25, 2018
    Manufacturer
    DORNIER MEDTECH SYSTEMS GMBH
    Product Code
    LNS
    PMA / PMN Number
    P840008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A CUSTOMER REQUESTED CONFERENCE CALL ON (B)(6) 2018, IT WAS NOTED BY THE CUSTOMER THAT THERE HAD BEEN A PAST UNREPORTED PATIENT DEATH ASSOCIATED WITH THIS SAME LITHOTRIPTER, (B)(4). ACCORDING TO THE CUSTOMER, THIS PATIENT DEATH WAS ON (B)(6) 2018 WITH THE ASSOCIATED ESWL TREATMENT PROCEDURE TAKING PLACE ON (B)(6) 2018. THIS WAS THE FIRST AND ONLY NOTIFICATION THAT DMTA RECEIVED CONCERNING THIS PARTICULAR PATIENT DEATH. IT WAS NOT MADE CLEAR BY THE CUSTOMER WHY THEY WAITED SO LONG TO REPORT THIS PATIENT DEATH TO DMTA. BOTH SERVICE REPORTS AND EMAIL CORRESPONDENCE WITH THE CUSTOMER, PROVIDED DOCUMENTED EVIDENCE THAT THE DEVICE WAS FOUND TO BE OPERATING WITH DORNIER SPECIFICATIONS. DORNIER MEDTECH AMERICA, INC. (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH SYSTEMS GMBH (THE MANUFACTURER) PER EXEMPTION NUMBER E2012002.

    Description of Event or Problem · 0

    PATIENT DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803099 COMPACT DELTA II LITHOTRIPTER LNS DORNIER MEDTECH SYSTEMS GMBH COMPACT DELTA II

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death