BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4122099 · Received September 26, 2014

    Report

    Report Number
    3006630150-2014-02202
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    January 11, 2013
    Report Date
    September 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A DURA TEAR. THE PATIENT WAS GETTING HEADACHES AND A COMPUTERIZED AXIAL TOMOGRAPHY (CAT) SCAN WAS PERFORMED. IT WAS DISCOVERED THAT THERE WAS A LITTLE HOLE THAT WAS LEAKING CEREBROSPINAL FLUID (CSF). IT WAS BELIEVED THAT THE PUNCTURE HAPPENED DURING PATIENT¿S IMPLANT PROCEDURE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE HOLE WAS SUTURED AND SEALED UP. THE PATIENT WAS REPORTEDLY DOING WELL, HAD NO MORE HEADACHE, AND WAS ON THE HEALING PROCESS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8216-50, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-5132, SERIAL #: (B)(4), DESCRIPTION: PRECISION SPECTRA EXTERNAL TRIAL STIMULATOR. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING HEADACHES WHEN THE TRIAL STIMULATOR WAS TURNED ON. THE PHYSICIAN BELIEVED THAT THE HEADACHE WAS DEVICE RELATED AND WAS A SPINAL HEADACHE. THE LEADS WERE REMOVED AND AN OCCIPITAL NERVE BLOCK WAS ADMINISTERED. THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING HEADACHES WHEN THE TRIAL STIMULATOR WAS TURNED ON. THE PHYSICIAN BELIEVED THAT THE HEADACHE WAS DEVICE RELATED AND WAS A SPINAL HEADACHE. THE LEADS WERE REMOVED AND AN OCCIPITAL NERVE BLOCK WAS ADMINISTERED. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600987 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention