BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2792253 · Received October 10, 2012

    Report

    Report Number
    1627487-2012-12247
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R 1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND A FIELD CORRECTION. 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

    IT WAS REPORTED THE PT DOES NOT HAVE STIMULATION COVERAGE DUE TO AN INABILITY TO CHARGE DUE TO MISSING POWER CORD. THE IPG WAS DEPLETED AND COULD NOT BE CHARGED WITH AN EXTRA CHARGER. THE PHYSICIAN REPLACED THE IPG. DURING THE PROCEDURE THE LEADS WERE TESTED AND INVALID IMPEDANCE WAS OBSERVED. A NEW LEAD WAS IMPLANTED. F/U DETERMINED THE PT HAS APPROPRIATE STIMULATION COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3063043

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT: