BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2210412 · Received August 9, 2011

    Report

    Report Number
    1627487-2011-01826
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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 4. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01827, 01828 AND 01829. THE PATIENT (B)(6) RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, TWO PERCUTANEOUS LEADS, AND TWO ANCHORS (FROM THE SAME LOT) ON (B)(6) 2009 FOR OCCIPITAL NEURALGIA. IT WAS REPORTED THAT THE PT LOST (B)(6) OVER THE LAST 2 YEARS, AND HER IPG, WHICH IS POSITIONED ON HER LEFT CLAVICLE REGION, HAS BECOME LOOSE AND FLOPPY. THE PT COMPLAINED OF A FEELING OF TIGHTNESS WITH HER LEADS AND TENDERNESS OVER HER CINCH ANCHORS. HER LEADS AND ANCHORS ARE POSITIONED IN THE LEFT OCCIPITAL REGION. SHE REPORTED THAT THE STIMULATION IS STILL PROVIDING GOOD PAIN RELIEF. X-RAYS REVEALED NO ANOMALIES TO THE SYSTEM. THE PHYSICIAN CONCLUDED THAT THE PT WILL REQUIRE SURGERY TO STABILIZE THE BATTERY, AND HE PLANS TO EXPLANT AND REPLACE THE LEADS AND ANCHORS. THE SURGERY DATE IS CURRENTLY UNDETERMINED AS NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2775351

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention