BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2050965 · Received April 12, 2011

    Report

    Report Number
    2182208-2011-00516
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTD
    PMA / PMN Number
    K982220
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. EVALUATION SUMMARY FOR (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD ADAPTOR HAD AN APPARENT FRACTURE, CAUSING THE LEAD IMPEDANCE TO DECREASE. THE ADAPTOR WAS REMOVED AND NOT REPLACED. TESTING OF THE LEADS, AFTER THE ADAPTOR WAS REMOVED FROM THE SYSTEM, FOUND IMPEDANCES TO BE WITHIN NORMAL RANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU IMPLANTABLE LEAD ADAPTOR DTD MEDTRONIC, INC. 2872 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 6944 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 2187 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB