BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 16357853 · Received February 10, 2023

    Report

    Report Number
    3006630150-2023-00540
    Event Type
    Injury
    Date Received
    February 10, 2023
    Date of Event
    December 1, 2018
    Report Date
    February 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED PRIOR TO 2019. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8116700, MODEL: SC-8116-70, SERIAL: (B)(4), BATCH: 143377.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. ALL DEVICE COMPONENTS WERE EXPLANTED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46738 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 166916

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention