BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 18179346 · Received November 20, 2023

    Report

    Report Number
    3006630150-2023-07226
    Event Type
    Injury
    Date Received
    November 20, 2023
    Date of Event
    April 25, 2023
    Report Date
    November 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    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. D6B: EXPLANT DATE: (B)(6) 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2138500, MODEL: SC-2138-50, SERIAL: (B)(6), BATCH: 133064/133271. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2138700 , MODEL: SC-2138-70, SERIAL: (B)(6), BATCH: 124270/138220.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS IPG WOULD NOT CHARGE. ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797762 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 162346

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention