BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 12888021 · Received November 29, 2021

    Report

    Report Number
    3006630150-2021-06794
    Event Type
    Injury
    Date Received
    November 29, 2021
    Date of Event
    November 26, 2019
    Report Date
    February 3, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1132 (SN: (B)(6). THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7053608/7062634.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT STIMULATION NOT REACHING HER TARGET AREAS DESPITE REPROGRAMMING ATTEMPTS. IT WAS ALSO REPORTED THAT SINCE IMPLANT, PATIENT STIIMULATION HAS BEEN IN THE WRONG AREA. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS STIMULATION WAS NOT REACHING HER TARGET AREAS DESPITE REPROGRAMMING ATTEMPTS. IT WAS ALSO REPORTED THAT SINCE IMPLANT, THE PATIENT STIMULATION HAS BEEN IN THE WRONG AREA. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1778691 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 205554 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention