BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 9628638 · Received January 24, 2020

    Report

    Report Number
    3006630150-2020-00180
    Event Type
    Injury
    Date Received
    January 24, 2020
    Date of Event
    September 1, 2010
    Report Date
    January 24, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE (B)(6) 2010 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. MODEL NUMBER/CATALOG NUMBER:SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5160874, MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A SPINAL CORD SYSTEM (SCS) TRIAL PROCEDURE THE PATIENT HAD A STAPHYLOCCOCUS INFECTION. IT WAS ALSO REPORTED THAT THE CAUSE OF INFECTION WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92277 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5160667 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention