BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYNC MAXIMO

    MDR report key: 2791154 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02110
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 3, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4). THE DEVICE WAS RETURNED AND ANALYZED. BOTH LOADED AND UNLOADED PACING CURRENT DRAIN LEVELS WERE NORMAL FOR THIS DEVICE OVER THE RANGE OF BATTERY VOLTAGE IT OPERATED UNDER DURING ITS SERVICE TIME. THERE IS NO EVIDENCE TO INDICATE A PROBLEM WITH THE BATTERY. HOWEVER, SINCE DEVICE DID HAVE A WRITE TO LOCKED RANDOM ACCESS MEMORY (RAM) POWER ON RESET (POR) THAT OCCURRED ON (B)(6) 2011, THIS COULD BE A POTENTIAL CAUSE FOR THE BATTERY TO DEPLETE. THE RESULT OF ANALYSIS IS INCONCLUSIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD BEEN PROGRAMMED PRIOR TO IMPLANT AND WAS FOUND AT ELECTIVE REPLACEMENT INDICATOR AND UNABLE TO BE PROGRAMMED OUT. THE DEVICE WAS NOT USED AND ANOTHER SELECTED FOR IMPLANT. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC MAXIMO IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7304

    Patients

    Seq Age Sex Outcome Treatment
    1 Other