BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4151802 · Received October 6, 2014

    Report

    Report Number
    1627487-2014-12657
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: BATCH RECORDS REVIEW FOR 4606184 SHOWED NON-CONFORMANCES RELATED TO INSUFFICIENT MATERIAL FROM THE WAREHOUSE, LABELING DEFECTS AND FOREIGN MATERIAL. SOME UNITS WERE REPLACED AND THE DEVICE SHOWN TO BE MANUFACTURED PER SPECS. SOME UNITS WERE REPRINTED AND THE REMAINING UNITS WERE SCRAPPED. AS NONCONFORMING UNITS WERE NOT DISTRIBUTED, THESE NON-CONFORMANCE COULD NOT HAVE CONTRIBUTED TO THE PRODUCT FAILURE IDENTIFIED IN THE COMPLAINT FOR 'INFECTION'. 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

    IT WAS REPORTED THE PT WENT TO THE EMERGENCY ROOM COMPLAINING OF PAIN AND SWELLING AT THE LEAD SITE AND WAS GIVEN PAIN MEDICATIONS SENT HOME. TWO DAYS LATER THE PT WAS SEEN BY THE IMPLANTING PHYSICIAN WHO NOTED SIGNS OF INFECTION. THE PT WAS ADMITTED TO THE HOSP AND IV ANTIBIOTICS WERE STARTED. THE PHYSICIAN FOUND THE LEAD SITE WAS INFECTED AND THE INFECTION HAD SPREAD TO THE IPG. BOTH DEVICES WERE EXPLANTED. CULTURES WERE TAKEN AND CONFIRMED A (B)(6) INFECTION. THE PT WAS SENT HOME AND WILL CONTINUE IV ANTIBIOTICS FOR SIX WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623369 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4606184

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization IMPLANT DATE:| SCS IPG, MODEL 3788,