BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1834193 · Received September 13, 2010

    Report

    Report Number
    1627487-2010-01750
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 1, 2007
    Report Date
    August 1, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 7. EVALUATION - 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. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. ANS 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    REFERENCE MANUFACTURER REPORTS: 1627487-2010-01744, 1627487-2010-01745, 1627487-2010-01746, 1627487-2010-01747, 1627487-2010-01748, AND 1627487-2010-01749. THE PT RECEIVED HER SCS SYSTEM WHICH INCLUDED FOUR PERCUTANEOUS LEADS TWO LEAD EXTENSIONS AND AN IPG ON (B)(6)2006. IN (B)(6)2006, THE LEADS REPORTEDLY BECAME INFECTED. THE PHYSICIAN EXPLANTED AND DISCARDED THE LEADS BUT LEFT THE IPG IMPLANTED WHILE THE ALLEGED INFECTION CLEARED. THE PT WAS SCHEDULED FOR A RE-IMPLANT DATE AROUND 9 MONTHS LATER. THE PHYSICIAN ADVISED THE PT TO CHARGE THE IPG PRIOR TO PRESENTING FOR THE LEAD IMPLANT PROCEDURE. THE PT HAD NOT CHARGED HER IPG SINCE THE ORIGINAL IMPLANT. IT WAS REPORTED THAT WHEN SHE ATTEMPTED TO RECHARGE, NO COMMUNICATION COULD BE ESTABLISHED BETWEEN THE IPG AND THE PT PROGRAMMER OR CHARGER. THE IPG WAS EXPLANTED AND REPLACED. THE EXPLANTED DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3716 57215

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention