BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVISTA MRI

    MDR report key: 8552079 · Received April 25, 2019

    Report

    Report Number
    3006630150-2019-01891
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    April 8, 2019
    Report Date
    June 3, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF SC-2408-56 (B)(4). THE COMPLAINT OF LEAD DAMAGE HAS BEEN CONFIRMED. THE LEAD BODY IS SEVERELY TWISTED AND COILED. THIS DAMAGE SUGGESTS THAT THE IPG ROTATED MULTIPLE TIMES IN THE POCKET RESULTING IN THE DEFORMATION OF THE LEAD. THE LEAD BODY WAS CLEAN CUT. THE CLEAN CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. ANALYSIS OF SC-2408-56 (B)(4). THE COMPLAINT OF LEAD DAMAGE HAS BEEN CONFIRMED. THE LEAD BODY IS SEVERELY TWISTED AND COILED. THIS DAMAGE SUGGESTS THAT THE IPG ROTATED MULTIPLE TIMES IN THE POCKET RESULTING IN THE DEFORMATION OF THE LEAD. SOME OF THE CABLES EVENTUALLY GOT FRACTURED DUE TO THE ROTATIONAL FORCE APPLIED ON THE LEAD BODY, CAUSING THE REPORTED HIGH IMPEDANCES. THERE ARE TRACES OF BLOOD AND CORROSION AT THE ENDS OF THE FRACTURED CABLES. THE INSULATION OF SOME OF THE CABLES WERE STRETCHED. THIS PROVES THAT THE DAMAGE OCCURRED WHEN THE LEAD WAS STILL IMPLANTED AND IT WAS DUE TO THE SEVERE TWISTING OF THE LEAD BODY. ADDITIONALLY, THE MOST OF THE CABLES WERE CLEAN CUT. THE CLEAN CUT CABLE DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT DURING A POCKET REVISION DUE TO PAIN (SEE MFR REPORT # 3006630150-2019-01796), THE PHYSICIAN SAW THAT BOTH LEADS WERE BROKEN. PRIOR TO THE PROCEDURE, THE PATIENT EXPERIENCED A LOSS OF STIMULATION AND HIGH IMPEDANCES NOTED ON ONE LEAD. THE LEADS WERE EXPLANTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: REFERENCE NUMBER: (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: (B)(4), MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A POCKET REVISION DUE TO PAIN (SEE MFR REPORT # 3006630150-2019-01796), THE PHYSICIAN SAW THAT BOTH LEADS WERE BROKEN. PRIOR TO THE PROCEDURE, THE PATIENT EXPERIENCED A LOSS OF STIMULATION AND HIGH IMPEDANCES NOTED ON ONE LEAD. THE LEADS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342905 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 21373101 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention