BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 11772877 · Received May 4, 2021

    Report

    Report Number
    3006630150-2021-01931
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    March 8, 2021
    Report Date
    May 26, 2021
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO BLOCK H6: UPDATED PATIENT CODE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500 MODEL: SC-2317-50 SERIAL: (B)(6) BATCH: 5132903.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE REPROGRAMMING SESSION THERE WERE HIGH IMPEDANCES FOUND ON 11 CONTACTS OF ONE OF THE LEADS WHEREIN CAUSING THE PATIENT TO EXPERIENCE INADEQUATE PAIN RELIEF. REPROGRAMMING WAS UNSUCCESSFUL AND THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE LEAD, HOWEVER THE PHYSICIAN ASSESSED THERE WAS TOO MUCH SCAR TISSUE PRESENT IN THE EPIDURAL SPACE AND WAS UNABLE TO REPLACE THE EXPLANTED LEAD. THE PATIENT WAS NOTED TO BE DOING WELL FOLLOWING THE PROCEDURE. THE LEAD WAS RETAINED BY FACILITY AND WAS NOT RETURNED. BOSTON SCIENTIFIC SUBSEQUENTLY RECEIVED INFORMATION INDICATING THAT THERE WAS A SECOND LEAD THAT WAS EXPLANTED ON THE SAME DATE OF THE ONE PREVIOUSLY REPORTED DUE TO HIGH IMPEDANCES CAUSING INADEQUATE PAIN RELIEF. THIS SECOND LEAD WAS ALSO DISCARDED AT THE FACILITY AND WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REPROGRAMMING SESSION THERE WERE HIGH IMPEDANCES FOUND ON 11 CONTACTS OF ONE OF THE LEADS WHEREIN CAUSING THE PATIENT TO EXPERIENCE INADEQUATE PAIN RELIEF. REPROGRAMMING WAS UNSUCCESSFUL AND THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE LEAD, HOWEVER THE PHYSICIAN ASSESSED THERE WAS TOO MUCH SCAR TISSUE PRESENT IN THE EPIDURAL SPACE AND WAS UNABLE TO REPLACE THE EXPLANTED LEAD. THE PATIENT WAS NOTED TO BE DOING WELL FOLLOWING THE PROCEDURE. THE LEAD WAS RETAINED BY FACILITY AND WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666773 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5135180 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention