BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 11766595 · Received May 3, 2021

    Report

    Report Number
    3006630150-2021-01912
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    March 25, 2021
    Report Date
    May 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7072185. PRODUCT FAMILY: SCS-IPG-R UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(4), BATCH: 376497.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD SITE AFTER A NON-DEVICE RELATED SURGERY. IT WAS NOTED THAT THE PATIENT HAD DRAINAGE FROM THE INCISION SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661970 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 3153757 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention