BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 6012430 · Received October 7, 2016

    Report

    Report Number
    3006630150-2016-02842
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-2218-50 SERIAL #: (B)(4) DESCRIPTION: LINEAR ST LEAD, 50CM MODEL#: SC-4316 LOT #: 19507118 DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO THE PATIENT WAS SHOWING NEUROLOGICAL SIGNS OF INFECTION. UPON FURTHER INVESTIGATION IT WAS STILL UNKNOWN ON WHY THE PATIENT WAS EXHIBITING NEURO ISSUES BUT SINCE THIS OCCURRED AROUND THE SAME TIME AS IMPLANT AND THE PHYSICIAN DECIDED TO DO THE EXPLANT. IT WAS ALSO NOTED THAT THERE WAS NO SIGNS OF INFECTION AT THE SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A SEVERE HEADACHE FOR UNKNOWN REASON. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A SEVERE HEADACHE FOR UNKNOWN REASON. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661679 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention