BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE

    MDR report key: 10791362 · Received November 5, 2020

    Report

    Report Number
    3006630150-2020-05372
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    October 13, 2020
    Report Date
    February 9, 2021
    Manufacturer
    OSYPKA AG
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED B26 POCKET ADAPTER WAS ANALYZED, HOWEVER, IT CANNOT BE CONFIRMED THAT THE POCKET ADAPTER WAS THE CAUSE OF THE IMPEDANCE ABNORMALITY. IT WAS SUSPECTED THERE WAS DAMAGE TO THE DEVICE WHICH OCCURRED DURING THE ORIGINAL IMPLANT PROCEDURE. IN ADDITION, THERE WAS DAMAGE TO THE DEVICE DURING THE ATTEMPT TO REMOVE THE NON-BOSTON SCIENTIFIC LEAD EXTENSION FROM THE B26 POCKET ADAPTER KIT. THE WELDS OF THE CRIMP SLEEVE TO CONTACT BLOCK C AND D WERE BROKEN. VISUAL INSPECTION REVEALED THAT THE SILICON COVER WAS DAMAGED AND TORN AWAY TO THE SET-SCREW TO CONTACT D. THE SET-SCREW TO CONTACT D WAS UNABLE TO ROTATE AS THE HEX SOCKET WAS SEVERELY DAMAGED. THE DAMAGE INCURRED AT BOTH PROCEDURES DOES NOT ALLOW FOR ELECTRICAL MEASUREMENTS. THEREFORE, THE CAUSE OF HIGH IMPEDANCES IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH IMPEDANCES AND UNDERWENT A PROCEDURE TO CONFIRM IF THE POCKET ADAPTER OR THE NON-BOSTON SCIENTIFIC LEAD EXTENSION WAS THE CAUSE OF HIGH IMPEDANCES. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO USE A TORQUE WRENCH TO REMOVE THE SCREW TO DISCONNECT THE ADAPTER FROM THE NON-BOSTON SCIENTIFIC LEAD EXTENSION, HOWEVER, THE ADAPTER SCREW WAS UNABLE TO BE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO USE THE CORRECT WRENCH, VARIOUS OTHER WRENCHES, RUBBER PADS AND SCISSORS BUT WAS STILL UNABLE TO REMOVE THE SCREW WHICH HAD THEN BEEN FLATTENED AND DAMAGED. THE PHYSICIAN THEN PULLED THE NON-BOSTON SCIENTIFIC LEAD EXTENSION FROM THE ADAPTER AND SEPARATED THE DEVICES. THE LEAD ADAPTER AND THE NON-BOSTON SCIENTIFIC LEAD WERE THEN CUT AND REMOVED FROM THE PATIENT. THE PHYSICIAN WAS UNABLE TO DETERMINE WHICH DEVICE WAS CAUSING THE HIGH IMPEDANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH IMPEDANCES AND UNDERWENT A PROCEDURE TO CONFIRM IF THE POCKET ADAPTER OR THE NON-BOSTON SCIENTIFIC LEAD EXTENSION WAS THE CAUSE OF HIGH IMPEDANCES. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO USE A TORQUE WRENCH TO REMOVE THE SCREW TO DISCONNECT THE ADAPTER FROM THE NON-BOSTON SCIENTIFIC LEAD EXTENSION, HOWEVER, THE ADAPTER SCREW WAS UNABLE TO BE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO USE THE CORRECT WRENCH, VARIOUS OTHER WRENCHES, RUBBER PADS AND SCISSORS BUT WAS STILL UNABLE TO REMOVE THE SCREW WHICH HAD THEN BEEN FLATTENED AND DAMAGED. THE PHYSICIAN THEN PULLED THE NON-BOSTON SCIENTIFIC LEAD EXTENSION FROM THE ADAPTER AND SEPARATED THE DEVICES. THE LEAD ADAPTER AND THE NON-BOSTON SCIENTIFIC LEAD WERE THEN CUT AND REMOVED FROM THE PATIENT. THE PHYSICIAN WAS UNABLE TO DETERMINE WHICH DEVICE WAS CAUSING THE HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259515 VERCISE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY OSYPKA AG DB-9418-15 P31135205

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention