BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2091618 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-01449
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT COULD NOT BE CONFIRMED VIA LABORATORY TESTING. 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

    DEVICE 1 OF 3. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01450 AND 1627487-2011-01451. THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND TWO SURGICAL LEADS, ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED ON (B)(6) 2011. THE PHYSICIAN FELT THAT THE PATIENT EXHIBITED SYMPTOMS OF A DEMYELINATING CONDITION AND NEEDED TO HAVE AN MRI. PRIOR TO THE EXPLANT SURGERY, THE PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS PREOPERATIVE. THE PHYSICIAN REPORTED THAT DURING THE EXPLANT PROCEDURE, HE NOTICED SOME PUS AT THE LEAD SITES AROUND THE ELECTRODE PADDLES. NO CULTURE WAS TAKEN. FOLLOW UP ON THE PATIENT FOUND THAT THE PATIENT WAS RECOVERING FROM THE EXPLANT SURGERY, AND NO FURTHER PATIENT COMPLICATIONS WERE 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 2884611

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention