BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EONC 16-CHANNEL IPG

    MDR report key: 1950383 · Received December 14, 2010

    Report

    Report Number
    1627487-2010-03914
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    SJM NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL - METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED FOUND A SUBLEVEL NONCOMFORMANCE, HOWEVER, THE DEVICE WAS REWORKED AND IT WAS DETERMINED NOT TO BE RELATED. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2010. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT PROGRAMMER HAD BEEN DISPLAYING THE "IPG LOW BATTERY" WARNING FOR THE PAST TWO WEEKS. IT WAS CONCLUDED THAT THIS WAS THE RESULT OF PASSIVATION, AND THE LOW BATTERY FLAG WAS CLEARED. THE DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW SJM NEUROMODULATION DIVISION 3688 2888419

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention