BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2081886 · Received April 5, 2011

    Report

    Report Number
    1627487-2011-00459
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 CORRECTED, AND THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. AS RECEIVED, A LAB CHARGING SYSTEM AND A TEST STANDARD CHARGING SYSTEM WERE BOTH ABLE TO LOCATE AND INITIATE A CHARGING CYCLE WITH THE RETURNED IPG. NO CHARGING ANOMALIES WERE NOTED. HOWEVER, THERE WERE DAMAGED BAL-SEAL SPRINGS IN THE LOWER HEADER PORT OF THE IPG, PREVENTING FURTHER INVESTIGATION OF ANY POTENTIAL DISCHARGE ISSUES. FROM THE AS RETURNED CHARGE LEVEL, THE IPG COMPLETED A CHARGE CYCLE IN NEARLY 2.5 HOURS. 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 AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT A PERCUTANEOUS LEAD AND LEAD EXTENSION WERE ADDED TO HIS SCS SYSTEM TO ADDRESS A NEW PAIN AREA. DURING THE PROCEDURE, THE PHYSICIAN REPLACED THE IPG DUE TO THE PT'S ALLEGATIONS OF INCREASED RECHARGE BURDEN AND COMMUNICATION ISSUES DURING RECHARGE OF THE IPG. EFFECTIVE STIMULATION WAS CAPTURED FOR THE PT FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3716 173395

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention