BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EONC

    MDR report key: 3001534 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-01267
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT OBSERVED THE IPG BATTERY LOW WARNING. AFTER REPLACING THE BATTERIES IN HIS PROGRAMMER AND SEVERAL ATTEMPTS TO COMMUNICATE, THE WARNING WENT AWAY. FOLLOW UP INFO IDENTIFIED THE IPG BATTERY LOW WARNING RETURNED. AN SJM REP MET WITH THE PT AND CLEARED THE FLAG. CALCULATION WERE DONE AND DETERMINED THE WARNING WAS CAUSED BY PASSIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94052 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3783324

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SCS LEAD: MODEL 3288| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)