BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3151472 · Received June 3, 2013

    Report

    Report Number
    1627487-2013-08182
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-08183. IT WAS REPORTED, THE PT NEITHER USED NOT CHARGED THE IPG (IMPLANTABLE PULSE GENERATOR) FOR SEVERAL YEARS AS HE WAS HAVING UNINTENDED STIMULATION IN ONE KIDNEY AND WAS NOT GETTING PAIN RELIEF. REPROGRAMMING ATTEMPTED DID NOT RESOLVE THE ISSUE. F/U INFO RECEIVED THE PT HAD DECIDED NOT TO HAVE ANY SURGICAL INTERVENTION TO ADDRESS THE ISSUE AND WILL KEEP THE DEVICE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242668 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 172630

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)