BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 9390471 · Received November 28, 2019

    Report

    Report Number
    3006630150-2019-06898
    Event Type
    Injury
    Date Received
    November 28, 2019
    Date of Event
    September 27, 2019
    Report Date
    February 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2317-50 SN: (B)(4). DEVICE EVALUATION INDICATED THAT THE LEAD PASSED ALL TESTS PERFORMED. SC-2317-50 SN: (B)(4). DEVICE EVALUATION INDICATED THAT THE COMPLAINTS OF HIGH IMPEDANCE HAVE BEEN CONFIRMED. VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT ALL CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT/KINKED LOCATION IS 1 CM FROM THE SET SCREW MARK OF THE CLIK ANCHOR. THERE ARE NO EXPOSED CABLES AT THE FRACTURE LOCATION. THE LEAD GOT KINKED AFTER IT EXITS THE CLIK ANCHOR RESULTING IN THE REPORTED COMPLAINT. IT APPEARS THAT THE LEAD WAS EXPOSED TO EXCESSIVE MECHANICAL FORCE OR MOVEMENT CAUSING THE CABLE FRACTURES RIGHT AT THE ANCHOR POINT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF DUE TO LEADS HAVING HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5041338, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF DUE TO LEADS HAVING HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184989 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 5039033 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention