BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2091625 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-01444
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: 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. THE DEVICE WAS, THEREFORE, APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. 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

    DEVICE 1 OF 5. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01445, 1627487-2011-01446, 1627487-2011-01447 AND 1627487-2011-01448. THE PATIENT RECEIVED TWO SCS SYSTEMS. ONE SYSTEM INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS, WAS IMPLANTED ON (B)(6) 2008. THE SECOND SYSTEM, INCLUDING AN IPG, SURGICAL LEAD AND ANCHOR, WAS IMPLANTED ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG POCKET SITE FOR THE LATTER SYSTEM. THE PHYSICIAN NOTED PUS AT THIS IPG SITE AND ALSO AT THE MIDBACK SITE WHERE THE SURGICAL LEAD WAS TUNNELED. THE PHYSICIAN ALSO REPORTED THAT THE TWO PERCUTANEOUS LEADS WERE EXPOSED WHEN THE MIDBACK INCISION SITE WAS OPENED. BOTH SYSTEMS WERE EXPLANTED ON (B)(6) 2011. A CULTURE WAS TAKEN AND THE RESULTS SHOWED (B)(6). THE PATIENT WAS ALLEGEDLY TREATED WITH INTRAVENOUS ANTIBIOTICS THEN ORAL ANTIBIOTICS. THE PHYSICIAN STATED, HE DID NOT FEEL THE INFECTION WAS PRODUCT RELATED. THE EXPLANTED DEVICES WERE SENT TO THE HOSPITAL PATHOLOGY DEPARTMENT; THEREFORE, THEY WILL NOT BE RETURNED TO THE MANUFACTURER.

    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 3131341

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R