BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 20651483 · Received November 11, 2024

    Report

    Report Number
    3006630150-2024-07732
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861539
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218500. MODEL: SC-2218-50 . SERIAL: (B)(6). BATCH: 20865425. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 20865425. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2218-50 SERIAL: 3033101 BATCH: 19275536

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON, DESPITE GOOD FAITH EFFORTS. NO ADDITIONAL INFORMATION WAS AVAILABLE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047843 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1032B 167032 08714729861539

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention