BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 20433848 · Received October 11, 2024

    Report

    Report Number
    3006630150-2024-06885
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    September 19, 2024
    Report Date
    October 11, 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
    CA, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2138700 MODEL: SC-2138-70 SERIAL: (B)(6) BATCH: 140397/140464.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER FUNCTIONING AS INTENDED. IT WAS ALSO STATED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED. T HERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISCARDED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301650 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 19804342 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention