BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIK X MRI

    MDR report key: 13163864 · Received January 5, 2022

    Report

    Report Number
    3006630150-2021-07467
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    October 8, 2021
    Report Date
    January 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905325
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION-MRI, UPN: M365SC43190, MODEL: SC-4319, SERIAL: NA, BATCH: 26368988. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 7070761. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL: (B)(4), BATCH: 7070563.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN NEAR THE ANCHOR SITE. THERE WERE NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED AS THEY WERE DAMAGED DURING THE PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159659 CLIK X MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4319 25871661 08714729905325

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention