BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 8732948 · Received June 25, 2019

    Report

    Report Number
    3006630150-2019-03042
    Event Type
    Injury
    Date Received
    June 25, 2019
    Date of Event
    June 10, 2019
    Report Date
    June 25, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797821
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-2366-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5000934, MODEL/CATALOG DESCRIPTION: LINEAR 3-6 LEAD 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS LEADS HAD MOVED IN THE OCCIPITAL AREA. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN ONE LEAD WAS ADDITIONALLY IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526042 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70 5031448 08714729797821

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention