BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3113306 · Received April 26, 2013

    Report

    Report Number
    1627487-2013-08027
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    May 1, 2009
    Report Date
    April 2, 2013
    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

    CORRECTION/REMOVAL NUMBER: 1627487-07262012-002-R, 1627487-12192011-003-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 REPORT: 1627487-2013-08028. IT WAS REPORTED THE PATIENT NEITHER USED NOR CHARGED THE IPG (IMPLANTABLE PULSE GENERATOR) SINCE SOMETIME IN 2009. SHE HAD HAD A FALL ABOUT 6 WEEKS AFTER THE IMPLANT AND SINCE THEN, THE STIMULATION WAS LIKE PINS AND NEEDLES DOWN BOTH LEGS. IT WAS STATED THE STIMULATION WAS INTOLERABLE EVEN AFTER REPROGRAMMING ATTEMPTS. X-RAY IMAGERY DID NOT REVEAL ANY PROBLEMS AND HENCE, THE SYSTEM REVISION WAS NOT OFFERED. IT WAS ALSO STATED THE PATIENT FELT HEATING AND WARMTH AT THE IPG SITE BUT NO REDNESS OR SWELLING WAS OBSERVED. THE PATIENT HAS AN APPOINTMENT WITH THE DOCTOR TO DISCUSS THE DEVICE EXPLANT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180763 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2757532

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention