BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 16613503 · Received March 24, 2023

    Report

    Report Number
    3006630150-2023-01540
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    February 27, 2023
    Report Date
    March 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729888734
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9218550, MODEL: SC-9218-55, SERIAL: (B)(4), BATCH: 7049698. PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9218550, MODEL: SC-9218-55, SERIAL: (B)(4), BATCH: 1078826. PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9218550, MODEL: SC-9218-15, SERIAL: (B)(4), BATCH: 7031652.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PERIPHERAL NERVE STIMULATION (PNS) PATIENT EXPERIENCED OCCASIONAL DISCOMFORT FOR SHORT PERIODS OF TIME AT THE LOCATION OF THE LEADS. THE PATIENT UNDERWENT AN EXPLORATORY PROCEDURE TO HELP DETERMINE THE SOURCE OF THE SENSATION, AND CORROSION WAS DISCOVERED ON SEVERAL OF THE NON-BOSTON SCIENTIFIC LEAD CONTACTS INSIDE THE ADAPTORS. IN ORDER TO CLEAN THE LEADS, THE ADAPTORS WERE DISASSEMBLED AND REPLACED. THE PATIENT DID WELL POSTOPERATIVELY. THE ADAPTORS WERE NOT RETURNED FOR ANALYSIS, AS THEY WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368224 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-9218-15 7063494 08714729888734

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention