BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3974002 · Received August 1, 2014

    Report

    Report Number
    3006630150-2014-01772
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEADS WERE NOT REPLACED. DEVICE MALFUNCTION WAS NOT SUSPECTED ON THE IPG. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2138-50, SERIAL #: (B)(4), DESCRIPTION: SCS 50CM III LEAD.

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE IPG 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR IPG CHANGE WAS INABILITY TO CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A LEAD REVISION AND AN IPG REPLACEMENT PROCEDURE FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A LEAD REVISION AND AN IPG REPLACEMENT PROCEDURE FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A LEAD REVISION AND AN IPG REPLACEMENT PROCEDURE FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A LEAD REVISION AND AN IPG REPLACEMENT PROCEDURE FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450965 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention