BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE 32

    MDR report key: 19131615 · Received April 18, 2024

    Report

    Report Number
    3006630150-2024-02431
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    December 26, 2023
    Report Date
    July 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729832676
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-8336-70 (SN (B)(6)). THE RETURNED LEAD WAS ANALYZED AND WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT WAS CONFIRMED. DAMAGE FOUND ON THE PADDLE LEAD IS LIKELY DUE TO EXPOSURE TO EXCESSIVE TENSILE FORCE WHEN THE LEAD MIGRATED, RESULTING IN ELECTRODE DISLODGEMENT AND PADDLE DAMAGE. A LABELLING REVIEW FOUND THAT THE REPORTED EVENT IS A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION.

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED COUPLE MONTHS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC, UPN: M365SC14320, MODEL: SC-1432, SERIAL: (B)(6), BATCH: 213915.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO A LEAD THAT MIGRATED AN ENTIRE LEVEL AND THERE APPEARS TO BE A SPLIT AT THE BOTTOM OF THE LEAD BETWEEN ELECTRODES AND LEAD TAILS APPEARED TO BE SLIGHTLY COILED NEAR THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPOSITIONED AND REMAINS IMPLANTED, AND THE LEAD WAS REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO A LEAD THAT MIGRATED AN ENTIRE LEVEL AND THERE APPEARS TO BE A SPLIT AT THE BOTTOM OF THE LEAD BETWEEN ELECTRODES AND LEAD TAILS APPEARED TO BE SLIGHTLY COILED NEAR THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPOSITIONED AND REMAINS IMPLANTED, AND THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513238 COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8336-70 7074634 08714729832676

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention