BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISAN

    MDR report key: 9434544 · Received December 6, 2019

    Report

    Report Number
    3006630150-2019-07164
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    November 18, 2019
    Report Date
    March 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-8120-70 (SN (B)(4)). DEVICE EVALUATION INDICATED THAT THE COMPLAINT OF LEAD DAMAGE HAD BEEN CONFIRMED. VISUAL INSPECTION FOUND THAT THE LEAD BODY INSULATION WAS DAMAGED EXPOSING SOME OF THE CABLES. IT APPEARED THAT A SMALL PORTION OF THE LEAD INSULATION WAS FRAYED. THE COMPLAINT OF HIGH IMPEDANCES ON SIX CONTACTS WAS NOT CONFIRMED. ELECTRICAL TEST ONLY FOUND ONE OPEN CONTACT AND IT WAS DUE TO A DISLODGED ELECTRODE IN THE PADDLE. VISUAL INSPECTION REVEALED THAT TWO OF THE PADDLE ELECTRODES WERE PARTIALLY DISLODGED AND ONE ELECTRODE WAS MISSING FROM THE PADDLE END OF THE LEAD. THIS TYPE OF DAMAGE OCCURED WHEN THE LEAD WAS EXPOSED TO EXCESSIVE TENSILE FORCE CAUSING THE LEAD BODY TO STRETCH AND EVENTUALLY BREAK RIGHT AT THE PADDLE END. THE DFU STATES THAT THE USER SHOULD AVOID DAMAGING THE LEAD WITH SHARP INSTRUMENTS OR EXCESSIVE FORCE DURING SURGERY. DFU ALSO STATES THAT THE USER SHOULD ENSURE THAT THERE IS ADEQUATE SPACE PRIOR TO INTRODUCING THE PADDLE LEAD. THE PROBABLE CAUSE SELECTED IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. ADDITIONALLY, OTHER SECTIONS OF THE LEAD BODY HAVE MULTIPLE BURN MARKS. THE BURN MARK WAS TYPICALLY CAUSED BY THE USE OF ELECTROCAUTERY DURING THE PROCEDURE. THIS TYPE OF DAMAGE IS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT DURING AN IPG REPLACEMENT PROCEDURE (MFR. REPORT NUMBER 3006630150-2019-07100), THE PHYSICIAN NOTICED THAT THE OUTSIDE OF THE LEAD SHEATH WAS OPEN AND THE INSIDE WIRE WAS EXPOSED. IT WAS NOTED THAT THE LEAD HAD HIGH IMPEDANCES. THE PHYSICIAN ALSO BELIEVED THAT THE LEAD WAS FRACTURED PRIOR TO SURGERY. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING AN IPG REPLACEMENT PROCEDURE (MFR. REPORT NUMBER 3006630150-2019-07100), THE PHYSICIAN NOTICED THAT THE OUTSIDE OF THE LEAD SHEATH WAS OPEN AND THE INSIDE WIRE WAS EXPOSED. IT WAS NOTED THAT THE LEAD HAD HIGH IMPEDANCES. THE PHYSICIAN ALSO BELIEVED THAT THE LEAD WAS FRACTURED PRIOR TO SURGERY. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224511 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-70 215121A

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention