BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EONC CONVENTIONAL IPG

    MDR report key: 2021366 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-01133
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT RECEIVED A "LOW IPG" WARNING MESSAGE. IT WAS REPORTED THAT THE PATIENT USES TWO PROGRAMS. BASED ON THE PROGRAMMED PARAMETERS, IT WAS ESTIMATED THAT THE IPG WOULD LAST APPROXIMATELY 45.1 MONTHS USING PROGRAM 1. THE IPG'S ESTIMATE OF LONGEVITY USING PROGRAM 2 WAS CALCULATED AS 10.9 MONTHS. IT IS UNKNOWN WHICH OF THE TWO PROGRAMS THE PATIENT USED MOST FREQUENTLY. FOLLOW UP ON THE PATIENT FOUND THAT THE IPG WILL BE REPLACED IN THE NEAR FUTURE; THE PROCEDURE DATE IS CURRENTLY UNDETERMINED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3688 114712

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention