BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION 16

    MDR report key: 16129909 · Received January 10, 2023

    Report

    Report Number
    3006630150-2022-07578
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    December 19, 2022
    Report Date
    March 2, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(4). BATCH: 7172981.

    Additional Manufacturer Narrative · 0

    SC-2316-50E SN: (B)(6). THE RETURNED LEAD WAS ANALYZED, AND VISUAL INSPECTION REVEALED THAT THE TOP SIX ELECTRODES ARE SEPARATED FROM THE DISTAL END. ELECTRODES 7-16, LEAD BODY, AND THE PROXIMAL END OF THE LEAD WAS NOT RETURNED. CABLES WERE EXPOSED AT THE FRACTURE LOCATION. VISUAL INSPECTION OF THE FRACTURED CABLES REVEALED FRAYING OF THE BREAKS, LACK OF NECKING AND DISCOLORATION ASSOCIATED WITH WELDING, AND THE PROXIMITY OF THE BREAK POINTS TO THE EDGE OF THE INSULATION INDICATED THAT THE CABLES DID NOT BREAK AT OR NEAR THE WELDS. IT APPEARED THAT RESISTANCE WAS FELT DURING THE LEAD PULL AND LEAD WAS SUBJECTED TO EXCESSIVE TENSILE LOAD CAUSING DAMAGE TO THE DISTAL ARRAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PERMANENT IMPLANT PROCEDURE, THE PHYSICIAN NOTICED THAT THERE WAS STILL PART OF THE TRIAL LEAD LEFT IN THE SUBCUTANEOUS TISSUE OF THE PATIENTS BODY. THE LEAD FRAGMENT WAS REMOVED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PERMANENT IMPLANT PROCEDURE, THE PHYSICIAN NOTICED THAT THERE WAS STILL PART OF THE TRIAL LEAD LEFT IN THE SUBCUTANEOUS TISSUE OF THE PATIENTS BODY. THE LEAD FRAGMENT WAS REMOVED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882707 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7172584 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention