BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2840055 · Received November 20, 2012

    Report

    Report Number
    3006630150-2012-02180
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2108-50M SERIAL #: (B)(4), DESCRIPTION: SCS LEAD KIT, PHASE 2 STERILE PACKAGE ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT BATTERY REPLACEMENT. DURING THE PROCEDURE, IT WAS FOUND OUT THAT THE LEAD WAS FRACTURED. THE LEADS WERE ALSO REPLACED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE 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 MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING DIFFICULTY CHARGING IPG. THE PHYSICIAN SUGGESTED REVISION DUE TO IPG IS COMPLETELY OUT OF POWER AND NEEDS REPLACEMENT FOR A NEW IPG.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING COMMUNICATION DIFFICULTIES WITH THE IPG AFTER SUCCESSFULLY CHARGING. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE TO REPLACE THE IPG.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING COMMUNICATION DIFFICULTIES WITH THE IPG AFTER SUCCESSFULLY CHARGING. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE TO REPLACE THE IPG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR