BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 10354369 · Received August 2, 2020

    Report

    Report Number
    3006630150-2020-03202
    Event Type
    Injury
    Date Received
    August 2, 2020
    Date of Event
    July 13, 2020
    Report Date
    August 2, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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-2317-70, SERIAL: (B)(4), BATCH: 5153219.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS STIMULATION COVERAGE WAS LOWER IN THE LEGS RATHER THAN IN THE BACK WHERE NEEDED DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED LEADS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818363 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5136596 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention