BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 11089361 · Received December 29, 2020

    Report

    Report Number
    3006630150-2020-06469
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    December 8, 2020
    Report Date
    December 29, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7103190.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT WAS EXPERIENCING RIGHT SIDED TENDERNESS. THE PATIENT HAD A LEAD PULL AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554593 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7101884 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention