BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIK X

    MDR report key: 9870839 · Received March 24, 2020

    Report

    Report Number
    3006630150-2020-01412
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    March 5, 2020
    Report Date
    March 24, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905318
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-1160, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 359036, MODEL/CATALOG DESCRIPTION: SPECTRA WAVEWRITER IPG KIT. MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5012507/5127953, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED CLIK ANCHOR WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE ANCHOR SITE. IT WAS ALSO REPORTED THAT THE PATIENT WAS HAVING DISCOMFORT AT THE IPG AND LEAD SITES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ANCHOR WAS EXPLANTED AND THE IPG AND LEADS WERE ADJUSTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335804 CLIK X STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4318 24107720 08714729905318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention