BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4189118 · Received October 21, 2014

    Report

    Report Number
    3006630150-2014-02392
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    July 26, 2014
    Report Date
    July 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM. MODEL #: SC-3138-35, SERIAL #: (B)(4), DESCRIPTION: SCS PHIII EXT 35CM. MODEL #: SC-1132, SERIAL #: (B)(4), DESCRIPTION: PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR. THE EXPLANTED LEADS WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE 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 A BURNING SENSATION ON HER LEFT SIDE WHERE THE IPG WAS, WHETHER STIMULATION WAS TURNED ON OR OFF AND A BURNING PAIN IN THE LOW BACK WHEN THE STIMULATION WAS TURNED ON. IT WAS ALSO REPORTED THAT DATABASE ANALYSIS REVEALED THE PATIENT¿S LEADS HAD HIGH IMPEDANCES AND WAS CAUSING THE PATIENT TO FEEL A ZING IN DIFFERENT POSTURAL POSITIONS. THE PATIENT WAS ALSO EXPERIENCING SORENESS DUE TO A LUMP IN THE BACK AND THE PHYSICIAN THOUGHT IT MIGHT BE HOW THE SITE OF THE CLIK ANCHOR HEALED. THE PHYSICIAN STATED THAT THERE WAS PROBABLY LEAD MALFUNCTION DUE TO THE WRONG ANCHORS USED. THE ANCHORS WERE NON BSC. THE PHYSICIAN WAS NOT SURE WHY THE LEAD BROKE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE REPLACED AND THE BURNING WENT AWAY. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667815 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention