BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1940646 · Received December 22, 2010

    Report

    Report Number
    1627487-2010-03881
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2010-03882. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2006, AND SHE RECENTLY UNDERWENT A LEAD REPLACEMENT PROCEDURE ON (B)(6) 2010 (REFERENCE MFR REPORT # 1627487-2010-03076). IT WAS REPORTED THAT BOTH THE RECHARGE BURDEN AND RECHARGE TIME FOR THE PT'S IPG HAS INCREASED. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PT. F/U ON THE PT FOUND THAT THE REPLACEMENT CHARGING SYS HAS IMPROVED THE ALLEGED RECHARGE ISSUES. A DIAGNOSTIC TEST OF THE PT'S LEAD HAS BEEN TAKEN AS WELL AS X-RAYS OF HER SCS SYS. THE PHYSICIAN IS PLANNING SURGICAL INTERVENTION TO REPLACE THE IPG AND THE LEAD IF NECESSARY. HOWEVER, A DATE FOR THE PROCEDURE HAS NOT BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3716 47484

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention