BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 15108879 · Received July 26, 2022

    Report

    Report Number
    3006630150-2022-03693
    Event Type
    Injury
    Date Received
    July 26, 2022
    Date of Event
    May 25, 2022
    Report Date
    July 26, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8116700, MODEL: SC-8116-70, SERIAL: (B)(4), BATCH: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE EXPLANTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341369 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 161866

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention