BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2152257 · Received June 22, 2011

    Report

    Report Number
    1627487-2011-01680
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFORMATION 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

    THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2009. THE PT REPORTED THAT SHE LOST STIMULATION, AND SHE WAS UNABLE TO ESTABLISH TELEMETRY BETWEEN HER CHARGER AND IPG. SHE STATED THAT SHE COULD NOT REMEMBER WHEN SHE LAST HAD STIMULATION BUT THAT IT HAD BEEN YEARS. A NEW CHARGING SYSTEM WAS SENT TO THE PT; HOWEVER, IT IS CURRENTLY UNDETERMINED WHETHER THE REPLACEMENT DEVICE RESOLVED THE ISSUE. NO FURTHER INFORMATION 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 2744440

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention IMPLANTE:| SCS LEAD, MODEL: 3219| SCS EXTENSION, MODEL: 3382 X 2| IMPLANTED: