BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 9443921 · Received December 10, 2019

    Report

    Report Number
    3006630150-2019-07219
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 30, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. X-RAY REVEALED THAT ONE OF THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT POLICE OFFICERS BROKE INTO PATIENTS HOME AND DESTROYED HIS BACK LEADS.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5092028, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. X-RAY REVEALED THAT ONE OF THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242006 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5092027 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention