BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2183613-2018-00177

    MDR report key: 7748801 · Received August 3, 2018

    Report

    Report Number
    2183613-2018-00177
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Date of Event
    August 2, 2018
    Report Date
    October 3, 2018
    PMA / PMN Number
    K971474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: ANALYSIS FOUND THAT THE SENSING WAS OUT OF CALIBRATION. THE DEVICE WAS CALIBRATED. THE DEVICE THEN PASSED FUNCTIONAL TESTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR (EPG) WAS RETURNED TO THE MANUFACTURER FOR INSPECTION. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Patients

    Seq Age Sex Outcome Treatment
    1