BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 12727546 · Received November 1, 2021

    Report

    Report Number
    3006630150-2021-06119
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    January 13, 2021
    Report Date
    November 1, 2021
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED HALF A YEAR FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(4), BATCH/LOT: 7073246/ 7073261.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT IS ALSO HAVING TO CHARGE THE BATTERY LONGER DUE TO THE BATTERY BEING CLOSE TO END OF LIFE. THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630563 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW SC-1132 18222807 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention