BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3173615 · Received June 17, 2013

    Report

    Report Number
    3006630150-2013-01217
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50E. SERIAL #: (B)(4), DESCRIPTION: TRIAL LINEAR ST LEAD, 50 CM. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED 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 MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING BETTER. NO FURTHER COURSE OF ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER THE TRIAL PROCEDURE, THE PATIENT WAS EXPERIENCING EXTREME PAIN IN HIS LEFT CALF. THE PHYSICIAN BELIEVED THE PAIN MAY HAVE BEEN PROCEDURE RELATED AND THE LEADS WERE PULLED OUT IMMEDIATELY. THE PATIENT WAS STILL IN EXTREME PAIN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER THE TRIAL PROCEDURE, THE PATIENT WAS EXPERIENCING EXTREME PAIN IN HIS LEFT CALF. THE PHYSICIAN BELIEVED THE PAIN MAY HAVE BEEN PROCEDURE RELATED AND THE LEADS WERE PULLED OUT IMMEDIATELY. THE PATIENT WAS STILL IN EXTREME PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273141 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention