BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3914472 · Received July 3, 2014

    Report

    Report Number
    3006630150-2014-01525
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DATABASE ANALYSIS SHOWED THE BATTERY DISCHARGE AND CHARGE PROFILE WERE OBSERVED AND REVEALED NO ANOMALIES. THE CHARGE PROFILE SHOWED THAT SIGNS OF POOR CHARGER TO IPG COUPLING AND THERMISTOR TRIGGERING WHICH LED TO PROLONGED CHARGING TIMES. HOWEVER, NOT ENOUGH CHARGING TIME WAS SPENT TO FULLY CHARGE THE BATTERY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ABLE TO GET THE IPG CHARGED AND WORKING. THE PATIENT WOULD NOT BE HAVING A REVISION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS REPORTEDLY DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S STIMULATOR WAS NOT WORKING. THE PATIENT WAS NOT ABLE TO CHARGE THE IPG. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S STIMULATOR WAS NOT WORKING. THE PATIENT WAS NOT ABLE TO CHARGE THE IPG. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S STIMULATOR WAS NOT WORKING. THE PATIENT WAS NOT ABLE TO CHARGE THE IPG. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S STIMULATOR WAS NOT WORKING. THE PATIENT WAS NOT ABLE TO CHARGE THE IPG. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390067 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR