BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 1072564 · Received July 10, 2008

    Report

    Report Number
    6000144-2008-00184
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    February 7, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: NO ANOMALIES WERE FOUND. OTHER: IT WAS REPORTED THAT THE ICD WAS REPLACED DUE TO SENSING DIFFICULTY, HIGH IMPEDANCE AND OVERSENSING. THE RV LEAD WAS ALSO REPLACED AT THE SAME TIME FOR OVERSENSING AND HIGH IMPEDANCE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ELECTRICAL TESTS PERFORMED; MECHANICAL TESTS PERFORMED. VISUAL EXAMINATION: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. DEVICE OPERATED ACCORDING TO SPECIFICATIONS. IMPEDANCE, HIGH, OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ICD WAS REPLACED DUE TO SENSING DIFFICULTY, HIGH IMPEDANCE AND OVERSENSING. THE RV LEAD WAS ALSO REPLACED AT THE SAME TIME FOR OVERSENSING AND HIGH IMPEDANCE. NO PATIENT COMPLICATIONS WERE 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 Required Intervention 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD