BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2000852 · Received February 17, 2011

    Report

    Report Number
    1627487-2011-01144
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-01145. THE PATIENT RECEIVED A REPLACEMENT IPG ON (B)(6) 2010 (REFERENCE MFR REPORT: 1627487-2011-01011). IT WAS REPORTED THAT THE PATIENT HAD A LEAD REPLACEMENT PROCEDURE (REFERENCE MFR REPORT: 1627487-2011-01010) ON (B)(6) 2011. THE NEW LEAD WAS REPORTED TO BE INSERTED INTO THE BOTTOM HEADER OF THE PATIENT'S EXISTING IPG AND EXHIBITED NORMAL IMPEDANCE READINGS DURING THE PROCEDURE. POSTOPERATIVELY, THE LEAD ALLEGEDLY REVEALED HIGH IMPEDANCE LEVELS. IT WAS REPORTED THAT THE PHYSICIAN TOOK THE PT BACK TO THE OPERATING ROOM ON (B)(6) 2011, AND HE CONFIRMED THE LEAD AND IPG WERE PROPERLY CONNECTED. HOWEVER, THE LEAD CONTINUED TO REVEAL HIGH IMPEDANCES ON ALL LEAD CONTACTS. THE PHYSICIAN STATED THAT HE THOUGHT THE IPG WAS CONTRIBUTING TO THE LEAD ISSUE. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE IPG AND THE LEAD. THE EXPLANTED DEVICES WERE RETURNED TO THE MFR FOR ANALYSIS. F/ U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3716 3145892

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention