BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 11649041 · Received April 12, 2021

    Report

    Report Number
    3006630150-2021-01504
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    December 1, 2019
    Report Date
    April 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED FOR ANALYSIS AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(4). BATCH: 5072039. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(4). BATCH: 5065919. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. SERIAL: N/A. BATCH: 21879884. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. SERIAL: N/A. BATCH: 21879884.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING CHRONIC LOWER BACK AND LEG PAIN THAT WAS EXACERBATED WHEN THE SCS SYSTEM WAS TURNED ON. THE PATIENT HAD FALLEN AND SUBSEQUENTLY HAD A CT MYELOGRAM OF HER SPINE WHERE NO ANOMALIES WERE OBSERVED. X RAYS PERFORMED ON THE LEADS SHOWED THAT THERE WAS NO MIGRATION. THE SCS SYSTEM WAS TURNED OFF FOR APPROXIMATELY 6 MONTHS. IT WAS TURNED ON BRIEFLY AND THE EXACERBATION OF THE PAIN APPEARED ABOUT 1 HOUR AFTER THE STIMULATION WAS TURNED ON. THE SCS SYSTEM WAS TURNED OFF SHORTLY AFTERWARDS. THE SCS SYSTEM WAS REVIEWED AGAIN AND THE LEADS IMPEDANCES WERE WITHIN THE NORMAL RANGE. THE IPG DATABASE WAS DOWNLOADED AND SENT FOR ANALYSIS. ANALYSIS OF THE IPG DATABASE REVEALED NO ANOMALIES. SEVERAL MONTHS LATER THE PATIENT UNDERWENT A TOTAL SCS SYSTEM EXPLANT DUE TO LACK OF EFFICACY AND FAILURE TO REDUCE CHRONIC PAIN. THE PATIENT WAS REPORTEDLY STABLE POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546113 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 206489 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention