BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 4832992 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07319
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 13, 2015
    Report Date
    March 13, 2015
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PATIENTS LEFT VENTRICULAR (LV) EPICARDIAL LEAD EXHIBITED HIGH THRESHOLDS AND WAS UNABLE TO CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378999 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R 5076-45, LEAD / 5076-52, LEAD / C2TR01, CRT-P