BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 15821252 · Received November 17, 2022

    Report

    Report Number
    3006630150-2022-06337
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    October 24, 2022
    Report Date
    November 17, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904823
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE APPROXIMATE. EXACT DATE UNKNOWN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9208150, MODEL: SC-9208-15, SERIAL: (B)(4), BATCH: 7071066. PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9208150, MODEL: SC-9208-15, SERIAL: (B)(4), BATCH: 7071073.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT, WHO WAS IMPLANTED WITH A NON-BOSTON SCIENTIFIC IMPLANTABLE PULSE GENERATOR, UNDERWENT AN EXPLANT OF THE ENTIRE SPINAL CORD STIMULATOR SYSTEM DUE TO INFECTION AND WOUND DEHISCENCE AT AN UNKNOWN LOCATION. THE PHYSICIAN STATED THAT THE WOUND DEHISCENCE WAS ATTRIBUTED TO THE INFECTION, AND THE EVENT WAS NOT A DEVICE SYSTEM ISSUE. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. NO FURTHER INFORMATION CAN BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322460 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-74 7074311 08714729904823

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention