BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 12253543 · Received July 30, 2021

    Report

    Report Number
    3006630150-2021-04233
    Event Type
    Injury
    Date Received
    July 30, 2021
    Date of Event
    June 15, 2021
    Report Date
    July 30, 2021
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 5031141. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 5017210.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PAIN AREA HAD MOVED FROM THE UPPER BACK TO THE LOWER BACK. THE PHYSICIAN WAS PLANNING ON ADDING TWO ADDITIONAL LEADS TO COVER THE NEW AREA. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE PHYSICIAN NOTICED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD MOVED UPWARDS TO THE SKIN, AND THE SKIN WAS A BIT OPENED ALREADY. THERE WERE NO SIGNS OF INFECTION. THE IPG AND LEADS WERE EXPLANTED AND THE PHYSICIAN IMPLANTED A NEW IPG ON THE PATIENT'S OTHER SIDE, AND IMPLANTED TWO NEW LEADS. THE EXPLANTED IPG AND LEADS WERE DISCARDED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151947 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 20768637 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention