BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 2230402 · Received August 15, 2011

    Report

    Report Number
    1627487-2011-08046
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 19, 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
    TX, 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 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 PATIENT RECEIVED THE SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE STIMULATION. THE PATIENT PROGRAMMER AND THE CHARGER WERE UNABLE TO LOCATE THE PATIENT'S IPG. THE PATIENT INDICATED THAT THE IPG HAD NOT BEEN CHARGED FOR (B)(6). A NEW CHARGER WAS SENT TO THE PATIENT. THE REPLACEMENT CHARGER WAS UNABLE TO RESOLVE THE ISSUE. THE PATIENT IS SCHEDULED FOR A REVISION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 176320

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3219 (2)