BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II DR

    MDR report key: 2813240 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06253
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    Z-0113-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERSENSING WAS SEEN ON THE RIGHT VENTRICULAR (RV) LEAD. DURING THE REVISION, THE DEVICE WAS ACCESSED AND WAS FOUND THAT THE PIN WAS NOT ENTIRELY THROUGH THE SETSCREW. THE LEAD WAS TESTED AND FOUND WITH A SLIGHTLY HIGH THRESHOLD. THE PHYSICIAN DECIDED TO RE-INSERT THE LEAD PAST THE SET SCREW AND CONTINUE TO MONITOR THE LEAD. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D284DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD