BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1940426 · Received December 20, 2010

    Report

    Report Number
    1627487-2010-03842
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE. HOWEVER, THE NONCONFORMANCE DID NOT AFFECT PRODUCT INTEGRITY OR FUNCTIONALITY AND PRODUCT 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. SJM HAS LIMITED INFORMATION 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT'S IPG POCKET SITE BECAME WARM AND RED AFTER CHARGING FOR APPROXIMATELY ONE HOUR. THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG; SHE STATED THAT SHE HAD PRESSED ON THE CHARGER ANTENNA TO LOCATE THE IPG. WITHIN TWO HOURS, THE REDNESS DISAPPEARED AT THE IPG POCKET SITE. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES 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 DIVISION 3788 3161555

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention