BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OVER THE WIRE LEAD

    MDR report key: 2131807 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10683
    Event Type
    Injury
    Date Received
    June 16, 2011
    Report Date
    July 23, 2020
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    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. DETAILED ANALYSIS OF THE DEVICE WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD HIGH THRESHOLDS AND HIGH OUTPUTS. THE LEAD WAS REMOVED 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
    1 ATTAIN OVER THE WIRE LEAD PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076X2 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076X2 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD