BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 18834059 · Received March 4, 2024

    Report

    Report Number
    3006630150-2024-01194
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    February 9, 2024
    Report Date
    March 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: 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: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH: 220104/220113 PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8120700 MODEL: SC-8120-70 SERIAL: (B)(6). BATCH: 233366A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALL COMPONENTS WERE EXPLANTED DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138838 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 184701 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention