BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 10706452 · Received October 20, 2020

    Report

    Report Number
    3006630150-2020-05008
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 20, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: M365SC2208700, MODEL: SC-2208-70, SERIAL: (B)(4), BATCH: 174600/185227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED DEVICES WERE NOT RETURNED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169487 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 176594

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention