BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3142173 · Received May 29, 2013

    Report

    Report Number
    1627487-2013-06358
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORIES. 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORTS: 1627487-2013-06359. THE PT WAS IMPLANTED WITH TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PT WAS EXPERIENCING PAIN AT HIS IPG SITE. IT WAS ALSO REPORTED THE PT EXPERIENCED A FALL AND THE SCS LEAD MIGRATED. ON (B)(6) 2013 THE PHYSICIAN WAS GOING TO REVISE BOTH THE IPG AND THE LEAD. HOWEVER, DURING INTRA-OP TESTING IT WAS FOUND THAT ONE OF THE LEADS HAD HIGH IMPEDANCE. THE LEAD WAS REPLACED WITH A NEW ONE. EFFECTIVE STIMULATION WAS CAPTURED POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235215 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3088846

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SCS ANCHOR: MODEL 1192 (X2)| IMPLANT DATE: