BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3031975 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-04384
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    September 21, 2012
    Report Date
    March 7, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-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 WAS INCLUDED IN 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-04383. IT WAS REPORTED THE PATIENT HAD A CONTINUED ISSUE IN WHICH THE STIMULATION WOULD AUTO-REDUCE. REPROGRAMMING ATTEMPTS WERE UNABLE TO RESOLVE THE ISSUE. IT WAS REPORTED THERE WERE MULTIPLE CONTACTS ON THE LEAD WHICH WERE INVALID. X-RAYS DID NOT REVEAL ANY ANOMALIES WITH THE SYSTEM. IT WAS ALSO REPORTED THE PATIENT HAD AN INCREASED RECHARGE BURDEN WITH THE IPG. THE PHYSICIAN PLANNED SURGICAL INTERVENTION AT A FUTURE DATE TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128654 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3240595

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1194