BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIGHT

    MDR report key: 19831141 · Received July 25, 2024

    Report

    Report Number
    3012165443-2024-00020
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    March 29, 2024
    Report Date
    July 25, 2024
    Manufacturer
    QUALITY TECH SERVICES LLC
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE ACCY B31040 LEAD TEST CABLE DBS (LOT #: 082N25423) REVEALED THAT THE SCREENING CABLE'S SPRING CONTACT ON THE DISTAL END WAS DAMAGED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OUTPUT WAS INCREASED TO 3V IN ALL COMBINATIONS OF UNIPOLAR BIPOLARS USING NUMBER 0 ELECTRODE, MEASUREMENT WAS TAKEN, AND THE VALUE BECAME HIGH BECAUSE MEASUREMENT COULD NOT BE PERFORMED ON THE CLINICIAN TABLET. EVEN AFTER ATTEMPTING TO RECONNECT THE CABLE SEVERAL TIMES IT DID NOT IMPROVE. WHEN ANOTHER LEAD TEST CABLE WAS BROUGHT IN AS A SPARE AND WAS OPENED AND CONNECTED, THE SITUATION IMPROVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) THAT THE CAUSE OF THE HIGH MEASUREMENTS WAS NOT DETERMINED. THE REP CLARIFIED THAT THIS EVENT OCCURRED DURING A STAGE 1 LEAD IMPLANT. A NEW LEAD KIT WAS OPENED ONLY FOR THE TEST CABLE. A NEW LEAD WAS NOT USED. THE TEST CABLE WAS REPLACED AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229934 SENSIGHT Stimulator, electrical, implanted, for parkinsonian tremor MHY QUALITY TECH SERVICES LLC B31040 082N25423

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female