BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 1921661 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05806
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    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) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD HIGH URGENCY DEVICE ALERT TONES, AND AN ALERT WAS RECORDED BY THE DEVICE. THE CAUSE OF THE ALERT IS UNKNOWN. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD HIGH URGENCY DEVICE ALERT TONES, AND AN ALERT WAS RECORDED BY THE DEVICE. THE CAUSE OF THE ALERT IS UNKNOWN. THE DEVICE IS STILL IN USE. THE DEVICE HAS REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND HAS BEEN EXPLANTED, REPLACED AND RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED 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 MED REL, INC. 7304 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACING LEAD| 2187 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD| 2187 IMPLANTABLE PACING LEAD