BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 5201457 · Received November 4, 2015

    Report

    Report Number
    2124215-2015-14523
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 12, 2015
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. THE DEVICE MANUFACTURE DATE FOR THIS PRODUCT IS AUGUST 23, 1996.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732725 ENDOTAK DSP IMPLANTABLE LEAD LWS HISTORICAL PUERTO RICO 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R 1861