BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II DR

    MDR report key: 2526272 · Received April 10, 2012

    Report

    Report Number
    6000144-2012-01772
    Event Type
    Injury
    Date Received
    April 10, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. TWO - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4)-2011 21:00:18 AND (B)(4)-2012 21:00:08. PROGRAMMER DATA FOR S2D FILE (B)(4) SHOWS "RV PACING LEAD IMPEDANCE NOT TAKEN" ON (B)(4)-2011 21:00:18 AND (B)(4)-2012 21:00:08.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAVE BEEN TWO ALERTS FOR RIGHT VENTRICULAR (RV) IMPEDANCE NOT TAKEN. NON-COMPETITIVE ATRIAL PACING (NCAP) WAS PROGRAMMED OFF. THE DEVICE REMAINS IN USE. NO PATIENT 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 84 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD