BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN BIPOLAR OVER THE WIRE LEAD

    MDR report key: 2200538 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11004
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    October 24, 2019
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS NOTED TO HAVE AN INSULATION DEFECT. THE INSULATION DEFECT WAS OBSERVED VISUALLY AND THE PHYSICIAN REPAIRED THE INSULATION. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN BIPOLAR OVER THE WIRE LEAD PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB