BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2201501 · Received August 3, 2011

    Report

    Report Number
    1627487-2011-05007
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2011. AT WAS REPORTED THAT SHE IS NOT FEELING STIMULATION AND THAT HER IPG IS DEPLETED. THE PT'S CHARGER ANTENNA HAS BEEN MISPLACED. SHE HAS NOT BEEN ABLE TO CHARGE HER IPG SINCE (B)(6) 2011. PT WAS SENT A NEW ANTENNA. ATTEMPT TO GATHER ADD'L INFO HAS BEEN UNSUCCESSFUL. 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 3240592

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other IMPLANT:| SCS LEAD ANCHORS: MODEL 1194 (2)| IMPLANT:| SCS LEAD: MODEL 3228