BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II DR

    MDR report key: 1990957 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00803
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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): PRELIMINARY ANALYSIS CONFIRMED HIGH IMPEDANCES AS WELL AS LOW PACING AMPLITUDES. THE SYMPTOMS CLEARED DURING ADDITIONAL TESTING AND THE FAILURE CONDITION COULD NOT BE RE-ESTABLISHED. CAUSE WAS UNDETERMINED. EVALUATION SUMMARY: (B)(4): PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED. STARTING WITH SAVE TO DISK (B)(4) FILE SAVED ON (B)(6) 2010 09:01:59 AND EARLIER ON WITH FILE (B)(4) SAVED ON (B)(6) 2010 18:29:51, SHOW NO DATA FOR THE WEEKLY, DAILY TRENDS, CAP-DETAIL AND CARDIAC COMPASS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND ADMITTED TO THE HOSPITAL DUE TO A DEVICE ALERT FOR INVALID DATA. THE DEVICE BATTERY VOLTAGE WAS NOT STABLE. IT WAS ALSO NOTED THAT THERE WERE HIGH THRESHOLDS ALONG WITH VARYING AND HIGH IMPEDANCES. THE DEVICE WAS EXPLANTED AND REPLACED. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD