BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON IPG

    MDR report key: 1963702 · Received December 21, 2010

    Report

    Report Number
    1627487-2010-03847
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 22, 2011
    Report Date
    November 22, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 AND THE PRODUCT WAS REPLACED AND RELEASED. THE DHR ANOMALY WAS UNRELATED TO THE ALLEGED DEVICE FAILURE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 REC'D HER SCS SYSTEM ON (B)(6) 2007. IT WAS REPORTED THAT THE PT LOST STIMULATION. THE PT'S PROGRAMMER WAS UNABLE TO COMMUNICATE WITH THE IPG. A REPLACEMENT EXTERNAL DEVICE WAS SENT TO THE PT. F/U ON THE PT REPORTED THAT PT PREFERRED TO WAIT UNTIL AFTER (B)(6) TO BE REPROGRAMMED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILAR ALLEGED EVENTS HAVE LED TO THE EXPLANT OF THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3716 65925

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention