BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 11915340 · Received June 1, 2021

    Report

    Report Number
    3006630150-2021-02559
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    April 1, 2021
    Report Date
    July 8, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC HAS DETERMINED THAT THE LOSS OF COVERAGE WAS MOST LIKELY DUE TO LEAD MIGRATION. LEAD MIGRATION IS A KNOWN INHERENT RISK WITH THE USE OF THE LEAD, AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). DEVICE TECHNICAL ANALYSIS ANALYSIS OF LEAD SC-2317-70 SERIAL (B)(6) REVEALED THAT THE DEVICE WAS CLEANLY CUT AND THE DISTAL PORTION WAS NOT RETURNED. NO ANOMALIES WERE IDENTIFIED ON THE LEAD ASIDE FROM THE CLEAN-CUT. THE DAMAGE TO THE LEAD IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. LEAD SC-2317-70 SERIAL (B)(6) WAS NOT RETURNED TO THE LABORATORY, THEREFORE A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. INVESTIGATION CONCLUSION: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC ENGINEERS DETERMINED THAT LEAD MIGRATION IS A KNOWN INHERENT RISK ASSOCIATED WITH USE OF THE DEVICE. PRODUCT LABELING STATES THAT LEAD MIGRATION RESULTING IN UNDESIRABLE CHANGES IN STIMULATION AND SUBSEQUENT REDUCTION IN PAIN RELIEF IS ONE OF THE POSSIBLE RISKS OF IMPLANTING THE DEVICE AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. NO ANOMALIES WERE NOTED ON THE RETURNED LEAD OTHER THAN THE CLEAN-CUT WHICH IS A RESULT OF A TYPICAL EXPLANT PROCEDURE. THE LABELING REVIEW REVEALED THAT THE LOSS OF COVERAGE IS A RESULT OF LEAD MIGRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DUE TO LEAD MIGRATION AND LOSS OF COVERAGE. THE PHYSICIAN REPLACED BOTH LEADS AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED LEADS WERE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7072413.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DUE TO LEAD MIGRATION AND LOSS OF COVERAGE. THE PHYSICIAN REPLACED BOTH LEADS AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813699 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5163943 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention