BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 15442170 · Received September 16, 2022

    Report

    Report Number
    3006630150-2022-04827
    Event Type
    Injury
    Date Received
    September 16, 2022
    Date of Event
    June 22, 2020
    Report Date
    September 16, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANT DATE: EITHER (B)(6) OR (B)(6), 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(4). LOT: 7092933.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT FOLLOWING A TRIAL SPINAL CORD STIMULATOR LEAD IMPLANT PROCEDURE, THE PATIENT WAS INSTRUCTED TO DISCONTINUE TAKING THEIR PRESCRIBED WARFARIN FOR FIVE DAYS POSTOPERATIVELY. ON THE LAST DAY, THE PATIENT EXPERIENCED A STROKE. THERE WERE RESIDUAL DEFICITS IN MEMORY AND THE RIGHT HAND SHOOK MAKING IT DIFFICULT TO WRITE. THE PATIENT ALSO STATED HAVING BALANCE ISSUES, HOWEVER, IT WAS NOT MADE CLEAR WHETHER THE BALANCE ISSUES ARE AT ALL ATTRIBUTED TO THE STROKE. THE PATIENT THEN UNDERWENT A TRIAL LEAD EXPLANT PROCEDURE IN ORDER TO ADMINISTER ANTICOAGULANTS. THE LOCATION OF THE LEADS IS UNKNOWN. THE EVENT WAS ASSESSED TO HAVE BEEN DUE TO THE PATIENT HAVING STOPPED TAKING THEIR PRESCRIBED MEDICINE FOR THE PRE-EXISTING CONDITION AND WAS NOT CONSIDERED TO BE RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652342 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7092815 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention| O