BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR

    MDR report key: 3142238 · Received May 29, 2013

    Report

    Report Number
    1627487-2013-10175
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2011
    Report Date
    May 11, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 3. REFERENCE MFR REPORT: 1627487-2013-10174, 10176. THE PT RECEIVED AN SCS SYSTEM WHICH INCLUDES THE IPG, TWO LEADS (FROM THE SAME LOT) AND TWO LEAD ANCHORS (FROM THE SAME LOT). THE PT REPORTED BEING IN SEVERE PAIN AND HAVING AN INFECTION SINCE IMPLANT. IN ADDITION, THE PT STATED THAT SHE WAS RECEIVING STIMULATION IN HER LUNGS AND HAS SUBSEQUENTLY TURNED THE SCS SYSTEM OFF. THE PT WAS ADVISED TO REPORT TO THE EMERGENCY ROOM. A F/U APPOINTMENT FOR REPROGRAMMING WAS SCHEDULED FOR (B)(6) 2013; HOWEVER, THE PT WAS UNABLE TO ATTEND AS SHE WAS HOSPITALIZED FOR CARDIAC ISSUES PERTAINING TO HER HISTORY OF CONGESTIVE HEART FAILURE. IT WAS NOTED, THE PT'S STAPLES WERE REMOVED ON (B)(6) 2013. F/U INFO REVEALED THE PT WAS PRESCRIBED BACTRIM FOR BLOODY DRAINAGE AT THE IPG POCKET. IT WAS ALSO REPORTED, THE PT WAS UNABLE TO ATTEND HER F/U APPOINTMENT ON (B)(6) 2013 AS SHE RETURNED TO THE EMERGENCY ROOM FOR CARDIAC SYMPTOMS. IT WAS NOTED, THE EMERGENCY ROOM PHYSICIAN STATED THE PT'S INCISIONS LOOKED GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234312 ANCHOR SCS LEAD ANCHOR GZB ST. JUDE MEDICAL - NEUROMODULATION 1192 3861775

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R