BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGABLE

    MDR report key: 2153369 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-00897
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    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
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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 # 1627487-2011-00898. THE PATIENT (B)(6) RECEIVED AN SCS SYSTEM INCLUDING AN IPG AND TWO LEADS. IT WAS REPORTED THAT THE PATIENT COULD FEEL NO STIMULATION EVEN AT MAXIMUM AMPLITUDE. IN ADDITION, SHE ALLEGED THAT THE RECHARGE BURDEN FOR HER IPG HAD SUDDENLY INCREASED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO REPLACE THE PATIENT'S IPG AND LEADS AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 2844881

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention