BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OVER THE WIRE LEAD

    MDR report key: 2200545 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11005
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    February 25, 2021
    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
    MA, 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. DETAILED ANALYSIS OF THE LEAD 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 DURING IMPLANT THE RIGHT VENTRICULAR (RV) LEAD HAD POSITIONING AND FIXATION DIFFICULTY. THE LEAD WAS NOT IMPLANTED AND A NEW LEAD WAS USED. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. THIS LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 64 YR Hospitalization| O| R 4193 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| D274TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIBRILLATOR| ICF09B IMPLANTABLE PACING LEAD| IML49B IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| ICF09B IMPLANTABLE PACING LEAD| D274TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIBRILLATOR| IML49B IMPLANTABLE PACING LEAD