BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 9794309 · Received March 5, 2020

    Report

    Report Number
    3006630150-2020-01003
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    February 11, 2020
    Report Date
    February 17, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2317-70. SERIAL/LOT: (B)(6). DESCRIPTION: INFINION CX LEAD KIT, 70CM DEVICES WERE DISCARDED BY FACILITY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2317-70. SERIAL/LOT: (B)(6). DESCRIPTION: INFINION CX LEAD KIT, 70CM. CORRECTION TO THE INITIAL MDR IN BLOCK H6; ADDED CODE A072201.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD LOSS OF STIMULATION AND HIGH IMPEDANCES. THE PHYSICIAN DECIDED TO PERFORM A REVISION PROCEDURE IN WHICH THE LEADS WERE REMOVED AND REPLACED WITH NEW LEADS. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD LOSS OF STIMULATION AND HIGH IMPEDANCES. THE PHYSICIAN DECIDED TO PERFORM A REVISION PROCEDURE IN WHICH THE LEADS WERE REMOVED AND REPLACED WITH NEW LEADS. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2317-70, SERIAL/LOT: (B)(4), DESCRIPTION: INFINION CX LEAD KIT, 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD LOSS OF STIMULATION AND HIGH IMPEDANCES. THE PHYSICIAN DECIDED TO PERFORM A REVISION PROCEDURE IN WHICH THE LEADS WERE REMOVED AND REPLACED WITH NEW LEADS. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254197 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5138691 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention