BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2133460 · Received June 15, 2011

    Report

    Report Number
    1627487-2011-03100
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    January 26, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. RESULTS - THE DEVICE WAS RETURNED ON (B)(6) 2011 FOR FURTHER ANALYSIS. IT WAS CONCLUDED THAT THE "INEFFECTIVE STIMULATION" WAS CONFIRMED. HOWEVER, THE IPG PASSED AUTOTEST AND FUNCTIONAL TESTS AND THERE WAS NO INVALID IMPEDANCE. THE RETURNED LEADS WERE SUSPECTED OF HAVING EXPLANT DAMAGE. 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

    PATIENT RECEIVED AN SCS ALONG WITH SURGICAL LEAD ON (B)(6) 2009. THE PATIENT WAS EXPLANTED ON (B)(6) 2011 DUE TO INEFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2867459

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SCS EXTENSION: MODEL 3342| SCS LEAD: MODEL 3186| IMPLANTED:| SCS LEAD: MODEL 3166 (2)| IMPLANTED:| SCS ANCHOR: MODEL 1194 (3)| IMPLANTED:| IMPLANTED: