BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 10500089 · Received September 7, 2020

    Report

    Report Number
    3006630150-2020-03969
    Event Type
    Injury
    Date Received
    September 7, 2020
    Date of Event
    August 11, 2020
    Report Date
    October 16, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2317-50, SN: (B)(6). THE RETURNED LEAD WAS ANALYZED AND IT WAS FOUND THAT THERE WERE FRACTURED CABLES AT THE CLICK SITE WHERE NO CABLES WERE EXPOSED DURING THE VISUAL AND XRAY INSPECTION. THE IMPEDANCE MEASUREMENT TEST CONFIRMED 15 FRACTURED CABLES. IT APPEARS THAT EXCESSIVE MECHANICAL/TENSILE FORCE WAS EXERTED ONTO THE LEAD, RESULTING IN THE CABLE FRACTURES. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT WAS CONFIRMED. THE LEAD GOT KINKED AFTER IT EXITS THE CLIK ANCHOR RESULTING IN THE REPORTED COMPLAINT. IT COULD BE CONCLUDED THAT THE PROBABLE CAUSE OF THE COMPLAINT WAS TRACED TO COMPONENT FAILURE. SC-2317-50, SN (B)(6): THE RETURNED LEAD WAS ANALYZED AND VISUAL INSPECTION SHOWED THAT THE LEAD BODY HAD A NICK AFTER THE Y-JUNCTION BY AN INSTRUMENT. AN XRAY INSPECTION CONFIRMED THAT A CABLE WAS SHARPLY CUT. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT WAS NOT CONFIRMED. THIS TYPE OF DAMAGE IS COMMON IN EXPLANT PROCEDURES AND WAS NOT CONSIDERED A SOURCE OF THE COMPLAINT. THEREFORE NO PROBLEM WAS DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES AS A RESULT THE PATIENTS PAIN AREAS ARE NOT COVERED BY STIMULATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. EXPLANTED LEADS WILL BE RETURNED.

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 21086446.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD HIGH IMPEDANCES AS A RESULT THE PATIENTS PAIN AREAS ARE NOT COVERED BY STIMULATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. EXPLANTED LEADS WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963103 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 21086446 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention