BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 10239646 · Received July 7, 2020

    Report

    Report Number
    3006630150-2020-02783
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    June 17, 2020
    Report Date
    November 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729904823
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE PERCUTANEOUS LEADS WERE REPLACED WITH A PADDLE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE NOT RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT PHYSICIAN THAT PUT IT IN, DAMAGED A NERVE AND AS A RESULT, THE PATIENT SPENT ABOUT A WEEK WITH A DILAUDID DRIP MEDICATION.

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7076839. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7072921.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE PERCUTANEOUS LEADS WERE REPLACED WITH A PADDLE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706360 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-74 5010505 08714729904823

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention