BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3862132 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06837
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 14, 2013
    Report Date
    March 18, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. PRODUCT ID (B)(4) ICD IMPLANTED: 2008 (B)(6); 5076-52 LEAD IMPLANTED: 2008 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SLIPPED ON ICE AND HAD A BAD AND THE NEXT DAY THERE WAS HIGH IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD. IT WAS NOTED THERE WAS COMPLETE FRACTURE OF THE LEAD. THE LEAD WAS CAPPED 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
    341522 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419388

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R 694265 LEAD