BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2190579 · Received July 25, 2011

    Report

    Report Number
    1627487-2011-06025
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 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

    EVALUATION: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE THAT DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY; THEREFORE, THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. AS RETURNED, THE IPG DID NOT RESPOND TO THE PATIENT PROGRAMMER OR THE BLUE SCREEN UTILITY. AFTER OPENING THE CAN, THE BATTERY WAS FOUND TO BE DEPLETED. THE BATTERY WAS RECHARGED AND DEFAULT PARAMETERS WERE RESTORED. THE HEADER UNDERWENT A THOROUGH CLEANING TO REMOVE DISCOLORATION, AND THE IPG PASSED AUTO TEST. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    THE PATIENT RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUDDEN LOSS OF STIMULATION AND WAS UNABLE TO COMMUNICATE WITH THE IPG USING TWO PROGRAMMERS AND TWO CHARGING SYSTEMS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO REPLACE THE PATIENT'S IPG, AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2775351

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention IMPLANT DATE:| IMPLANTED:| SCS LEAD EXTENSION, MODEL: 3386| SCS LEAD, MODEL UNK