BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 12111241 · Received July 2, 2021

    Report

    Report Number
    3006630150-2021-03456
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    June 9, 2021
    Report Date
    July 2, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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-2317-70 SERIAL:(B)(4). BATCH: 5072045.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF PATIENTS PERCUTANEOUS LEADS HAD PULLED DOWN TWO VERTEBRAL BODIES, AND WAS NOT HAVING STIMULATION IN AREAS NEEDED AND WAS ABLE TO REPROGRAMMED. THE PATIENT UNDERWENT LEADS REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007577 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5058069 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention