BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3193556 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-04797
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 4, 2013
    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: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, 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

    IT WAS REPORTED THE PT HAD REDNESS AT THE THORACIC LEAD INCISION WHICH WAS SENSITIVE TO THE TOUCH. IT WAS REPORTED THE INCISION WAS WASHED AND THE PT WAS PLACED ON IV ANTIBIOTICS FOR 3 WEEKS AND THEN ORAL ANTIBIOTICS. FOLLOW-UP IDENTIFIED THAT PT HAD A SUBCUTANEOUS INFECTION. IT WAS REPORTED THE SCS SYSTEM WAS NOT REMOVED, AND THE PT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287282 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3969235

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other SCS IPG, MODEL 3788| IMPLANT DATE: