BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 16812895 · Received April 26, 2023

    Report

    Report Number
    3006630150-2023-02285
    Event Type
    Malfunction
    Date Received
    April 26, 2023
    Date of Event
    March 4, 2023
    Report Date
    May 24, 2023
    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
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4). BATCH: 7080750.

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK H6. SC-2317-70 (SN:(B)(6)) THE RETURNED LEAD WAS ANALYZED, AND VISUAL INSPECTION REVEALED THAT THE LEAD WAS CLEANLY CUT INTO TWO PIECES APPROXIMATELY 25.5 CM FROM THE PROXIMAL END OF THE LEAD. THE DISTAL END OF THE LEAD WAS NOT RETURNED. THE CLEAN-CUT DAMAGE WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTION OF THE LEAD. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE ALLEGATION OF LEAD MIGRATION HAS BEEN CONFIRMED DURING THE REVISION. 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. THEREFORE, THIS INVESTIGATION IS ASSIGNED A PROBABLE CAUSE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION DUE TO HIGH IMPEDANCES FROM A FALL. DURING THE REVISION IT WAS FOUND OUT THAT ONE OF THE LEADS HAD FRACTURED COMPLETELY AND WAS HALFWAY IN THE EPIDURAL SPACE AND HALF OUT. THE PHYSICIAN OPTED TO EXPLANT THE LEADS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION DUE TO HIGH IMPEDANCES FROM A FALL. DURING THE REVISION IT WAS FOUND OUT THAT ONE OF THE LEADS HAD FRACTURED COMPLETELY AND WAS HALFWAY IN THE EPIDURAL SPACE AND HALF OUT. THE PHYSICIAN OPTED TO EXPLANT THE LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791414 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7080672 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention