BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSIGN

    MDR report key: 10303577 · Received July 21, 2020

    Report

    Report Number
    8021774-2020-00004
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Report Date
    June 22, 2020
    Manufacturer
    THE MAGSTIM COMPANY LTD.
    Product Code
    ETN
    PMA / PMN Number
    K923056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE POTENTIOMETERS (22K LOG 475048), VR1 ON THE 2527-01 FRONT PANEL PCB AND VR1 ON THE 2528-01 PIGGY BACK PCBARE WORN AND REQUIRE REPLACEMENT. THE WORN POTENTIONMETER IS THE ROOT CAUSE. TREND ANALYSIS: A REVIEW WAS PERFORMED OF SIMILAR INCIDENTS, FROM 01 JANUARY 2017 TO 22 JUNE 2020 (AWARENESS DATE). ONLY ONE SIMILAR EVENT WAS NOTED, WITH OUR REFERENCE CC 954. HOWEVER, UPON RE-ASSESSMENT OF THE RISK ASSOCIATED WITH THIS EVENT (CC 954), IT WAS CONCLUDED THAT THE DEVICE HAD EXCEEDED ITS LIFETIME. OUT OF THE LIFETIME OF A DEVICE, IT CAN BE REASONABLY EXPECTED TO START TO SHOW WEAR AND TEAR. A TREND IN A FAULTY/WORN POTENTIOMETER IN THIS DEVICE WITHIN ITS LIFETIME, IS NOT CURRENTLY SHOWING. WE WILL KEEP MONITORING THIS IN LINE WITH OUR COMPLAINT HANDLING PROCEDURE AND TAKE CORRECTIVE AND PREVENTIVE ACTIONS WHERE REQUIRED. NOTE: WE WERE INFORMED THAT THE ISSUE DID NOT OCCUR IN DENMARK BUT IN SWEDEN. THE DISTRIBUTOR IS BASED IN DENMARK, AND THE CUSTOMER IN SWEDEN.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INVESTIGATION. THERE IS EVIDENCE TO SUGGEST THAT THE POTENTIOMETER WAS THE CAUSE OF THE ISSUE. FURTHER INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATOR PRESENTED A VERY WEAK SOUND, EVEN WITH THE HIGHEST CURRENT. NO ACTUAL INCIDENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765242 NEUROSIGN NEUROSIGN 100 ETN THE MAGSTIM COMPANY LTD. 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 1020-00 MUTE SENSOR - SN (B)(6).| 1719-00 N100 PREAMPLIFIER POD - SN (B)(6).| 9967-00 STIMULATOR POD - SN (B)(6).