BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 16608161 · Received March 24, 2023

    Report

    Report Number
    3006630150-2023-01526
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    February 6, 2023
    Report Date
    May 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8116700. MODEL: SC-8116-70. SERIAL: (B)(4). BATCH: 130287.

    Additional Manufacturer Narrative · 0

    SC-1416 (SN: (B)(6)) THE RETURNED IPG WAS ANALYZED, PASSED ALL TEST PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-8116-70 (SN: (B)(6)) THE RETURNED LEAD WAS ANALYZED AND VISUAL INSPECTION REVEALED THAT THE DISTAL ARRAY WAS DETACHED FROM THE LEAD BODY. THE SILICONE OVER MOLD WAS SHEARED OFF BETWEEN THE CONTACT SLEEVE OF E8 AND THE RETAINER SLEEVE, AND THE CONTACT SLEEVE OF E8 SHOWED A SEVERED INDENTATION CAUSED BY THE SET SCREW. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED ALLEGATION OF HIGH IMPEDANCE WAS DISCOVERED ON THE LEAD WAS CONFIRMED. THIS SUGGESTS THAT THE LEAD WAS NOT FULLY INSERTED IN THE IPG HEADER. WHEN CONTACTS WERE NOT PROPERLY ALIGNED IN THE IPG HEADER, IT CAUSED HIGH IMPEDANCE READINGS. THEREFORE, THE PROBABLE CAUSE SELECTED IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IPG WAS NO LONGER FUNCTIONING AS INTENDED. NO DEVICE MALFUNCTION SUSPECTED. DURING THE PROCEDURE TO REPLACE THE IPG, THERE WERE ISSUES WITH THE SCREW AND HIGH IMPEDANCE WAS ALSO DISCOVERED ON THE LEAD. THE PHYSICIAN HAD TO CUT THE LEAD AND THE IPG WAS REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IPG WAS NO LONGER FUNCTIONING AS INTENDED. NO DEVICE MALFUNCTION SUSPECTED. DURING THE PROCEDURE TO REPLACE THE IPG, THERE WERE ISSUES WITH THE SCREW AND HIGH IMPEDANCE WAS ALSO DISCOVERED ON THE LEAD. THE PHYSICIAN HAD TO CUT THE LEAD AND THE IPG WAS REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REMAINING PART OF THE PADDLE LEAD WAS ABANDONED AND WILL NOT BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367816 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1416 206383 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention