BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 4830026 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06318
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 16, 2015
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD THRESHOLDS WERE HIGH AND THE LEAD HAD PULLED BACK. THE LEAD WAS PROGRAMMED OFF AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376075 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R C154DWK ICD, 7121 LEAD, 1782TC LEAD