BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 18855816 · Received March 7, 2024

    Report

    Report Number
    3006630150-2024-01269
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    July 27, 2017
    Report Date
    March 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6). BATCH: 5020135/21505469/5081395 PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216700 MODEL: SC-8216-70 SERIAL: (B)(6). BATCH: 19085054

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED PAIN DOWN THE LEG AFTER FALLING ON THE SIDE WHERE THE IPG WAS LOCATED. IT WAS ALSO NOTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE REMOVED AND KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880481 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 20787526 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention