BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 10085767 · Received May 25, 2020

    Report

    Report Number
    3006630150-2020-02213
    Event Type
    Injury
    Date Received
    May 25, 2020
    Date of Event
    May 4, 2020
    Report Date
    June 25, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT WAS EXPERIENCING PAINFUL SENSATION IN THE LEG AND SPASM IN THE SACRAL AREA. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEAD MIGRATION CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE. ADDITIONAL INFORMATION RECEIVED THAT INITIALLY THE PHYSICIAN WAS NOT ABLE TO GET THE LEADS AS HIGH BUT THE PATIENT HAD GOOD COVERAGE. HOWEVER, THE LEADS MOVED ON THE SECOND DAY WHICH GAVE THE PATIENT THE ISSUES MENTIONED PREVIOUSLY. THE PATIENT HAD AN EARLY LEAD PULL AND WILL PROCEED WITH THE PERMANENT IMPLANT PROCEDURE. THERE WAS NOTHING ABNORMAL WITH THE LEADS OR THE TRIAL PROCEDURE. THE EXPLANTED LEADS WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-2316-50E; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 7083133; MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT WAS EXPERIENCING PAINFUL SENSATION IN THE LEG AND SPASM IN THE SACRAL AREA. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEAD MIGRATION CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548664 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7082883 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention