BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2051299 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01367
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    November 22, 2010
    Report Date
    March 10, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS FOUND NONCONFORMANCES RELATED TO THE PRODUCT. PRODUCT WAS REPLACED OR REWORKED AND RELEASED FOR USE. THE DHR ANOMALIES WERE NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. VISUAL ANALYSIS OF THE IPG NOTED SOME DISCOLORATION ON THE UPPER CANAL OF THE IPG HEADER. A HIGH RESISTANCE SHORT WAS FOUND BETWEEN CHANNELS 1 AND 9 WHERE THE FEEDTHRU WIRES EXIT THE CAN. VISUAL EXAMINATION UNDER A MICROSCOPE REVEALED A DENDRITIC GROWTH (UNIDENTIFIED CONTAMINATION-METALLIC GROWTH) BETWEEN CHANNEL 1 AND 9. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO 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 HIS SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THE PT'S IPG GRADUALLY REQUIRED MORE FREQUENT RECHARGING. REPROGRAMMING EFFORTS AND A REPLACEMENT CHARGING SYSTEM WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. THE PHYSICIAN EXPLANTED AND REPLACED THE PT'S IPG WITH A DIFFERENT MODEL ON (B)(6) 2011. THE PT REPORTED EFFECTIVE STIMULATION POSTOPERATIVE, AND NO FURTHER PT ISSUES WERE REPORTED.

    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 DIV 3788 3158083

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention