BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 15076425 · Received July 21, 2022

    Report

    Report Number
    3006630150-2022-03593
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    December 1, 2022
    Report Date
    September 1, 2022
    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
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED LEAD WAS ANALYZED AND REVEALED THAT ONE OF THE CABLES AT THE DISTAL END WAS PULLED OUT AND THE LEAD BODY WAS SHARPLY LACERATED BY A TOOL ABOUT 16 CENTIMETERS FROM THE PROXIMAL END. THE CONTINUITY TEST REVEALED THAT 6 ELECTRODES WERE OPEN. THE DAMAGE TO THE LEAD IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IS NOT CONSIDERED THE SOURCE OF THE COMPLAINT. NO OTHER ANOMALIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7073439. AN ADDITIONAL LEAD WAS RECEIVED AND PHYSICAL ANALYSIS OF THIS RETURNED LEAD SC-2317-70 SERIAL NUMBER: (B)(6) REVEALED THE LEAD WAS CLEANLY CUT WITH 5 ELECTRODES MISSING FROM THE DISTAL END; DAMAGE THAT RESULTS FROM A TYPICAL EXPLANT PROCEDURE AND IS NOT CONSIDERED A DEVICE FAILURE. HOWEVER, ANALYSIS ALSO REVEALED SEVERAL FRACTURED CABLES AT THE CLIK ANCHOR SITE, NEAR THE PROXIMAL END. THIS FINDING IS THE LIKELY CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF STIMULATION DUE TO HIGH IMPEDANCES ON THE LEAD. REPROGRAMMING WAS ATTEMPTED MULTIPLE TIMES, BUT WAS UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD WAS REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF STIMULATION DUE TO HIGH IMPEDANCES ON THE LEAD. REPROGRAMMING WAS ATTEMPTED MULTIPLE TIMES, BUT WAS UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD WAS REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED PROVIDING THE SERIAL NUMBER OF THE EXPLANTED LEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF STIMULATION DUE TO HIGH IMPEDANCES ON THE LEAD. REPROGRAMMING WAS ATTEMPTED MULTIPLE TIMES, BUT WAS UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD WAS REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434435 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7073440 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention