BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1924439 · Received December 7, 2010

    Report

    Report Number
    1627487-2010-03900
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    July 21, 2010
    Report Date
    November 8, 2010
    Manufacturer
    SJM NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT, HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED 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. ANS HAS LIMITED INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED ON (B)(6) 2010, THAT THE IPG BATTERY WAS NOT HOLDING A CHARGE. THE PT WAS GIVEN A NEW PROGRAMMER BUT CONTINUED TO RECHARGE FREQUENTLY. THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2010. AFTER THE PROCEDURE IT WAS REPORTED THAT THE PT HAD GOOD STIMULATION COVERAGE AND THAT THE RECHARGE BURDEN APPEARS NORMAL. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW SJM NEUROMODULATION 3788 2812360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention