BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 12238289 · Received July 28, 2021

    Report

    Report Number
    3006630150-2021-04088
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    June 28, 2021
    Report Date
    July 28, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED A WEEK AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(4), BATCH: 7071321.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DRAINAGE AT THE IPG SITE. THE PATIENT WAS GIVEN ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134115 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 202763 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention