BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4948093 · Received July 28, 2015

    Report

    Report Number
    3006630150-2015-01958
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2317-50, SERIAL #: (B)(4), DESCRIPTION: INFINIONTM CX 50 CM LEAD.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A PERMANENT IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A DURA PUNCTURE. THE PATIENT HAD NO SYMPTOMS AND RECEIVED A BLOOD PATCH. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488481 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention