BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 8654566 · Received May 30, 2019

    Report

    Report Number
    3006630150-2019-02539
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    May 10, 2019
    Report Date
    July 16, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1132 (SN: (B)(4)). DEVICE EVALUATION INDICATED THAT THE IPG PASSED ALL TESTS PERFORMED. SC-8336-50 (SN: (B)(4)). DEVICE EVALUATION INDICATED THAT THE PATIENT WAS EXPLANTED DUE TO INADEQUATE STIMULATION. VISUAL INSPECTION FOUND THE LEAD WAS CLEANLY CUT. X-RAY INSPECTION FOUND NO OTHER DAMAGES EXCEPT THE INTENTIONAL CUT. THE DEVICE DAMAGE WAS SIMILAR TO THE TYPICAL EXPLANT DAMAGE AND WAS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-8336-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 21328764, MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448620 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 201955 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention