BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 11576224 · Received March 26, 2021

    Report

    Report Number
    3006630150-2021-01241
    Event Type
    Malfunction
    Date Received
    March 26, 2021
    Date of Event
    March 4, 2021
    Report Date
    April 7, 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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD WITH NONFUNCTIONAL CONTACTS AND HIGH IMPEDANCES WERE NOTED. THE PATIENT HAD A SEIZURE THAT HAD CAUSED SIGNIFICANT MUSCLE SPASMS AND JERKING OF HER EXTREMITIES WHICH MAY HAVE BROKEN SOME OF THE WIRES WITH HER SCS SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO HIGH IMPEDANCE ON THE LEADS. IT WAS ALSO NOTED THAT THE PATIENTS SEIZURE WAS NOT RELATED TO THE DEVICE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT 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: (B)(4), MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7071354.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SEIZURE THAT HAD CAUSED SIGNIFICANT MUSCLE SPASMS AND JERKING OF HER EXTREMITIES WHICH MAY HAVE BROKEN SOME OF THE WIRES WITH HER SCS SYSTEM. IT WAS ALSO NOTED THAT THE PATIENTS CONTACTS HAD HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475145 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 7071291 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention