BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE? 32

    MDR report key: 24517638 · Received March 5, 2026

    Report

    Report Number
    3006630150-2026-01282
    Event Type
    Injury
    Date Received
    March 5, 2026
    Date of Event
    January 13, 2026
    Report Date
    March 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729832669
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND THE COMPLAINT AS REPORTED COULD NOT BE CONFIRMED. RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT AND THE CONCLUSION CODE KNOWN INHERENT RISK OF DEVICE WILL BE USED. CORRECTION TO FIELD H11: ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-1232. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 770855. MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA 32 IPG KIT. UNIQUE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO SPINAL CORD STIMULATOR (SCS) PADDLE LEAD HAD PULLED OUT OF THE EPIDURAL SPACE WHICH WAS CONFIRMED THROUGH XRAY. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEAD WAS REPLACED AND THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO SPINAL CORD STIMULATOR (SCS) PADDLE LEAD HAD PULLED OUT OF THE EPIDURAL SPACE WHICH WAS CONFIRMED THROUGH XRAY. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEAD WAS REPLACED AND THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE IPG WAS REPLACED ALONG WITH THE PADDLE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111377 COVEREDGE? 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-8336-50 7072284 08714729832669

    Patients

    Seq Age Sex Outcome Treatment
    1