BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 8645852 · Received May 28, 2019

    Report

    Report Number
    3006630150-2019-02497
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    March 15, 2019
    Report Date
    July 8, 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 DEVICE PASSED ALL TESTS PERFORMED. SC-8336-50, SN (B)(4): DEVICE EVALUATION INDICATED THAT VISUAL INSPECTION FOUND THE LEAD WAS CLEANLY CUT DURING THE EXPLANT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8336-50. (B)(4). BATCH/LOT NUMBER: 7005415. MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438827 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 204184 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention