BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3052311 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-13519
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 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

    EVALUATION: 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 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 1 OF 3. REFERENCE MFR. REPORT: 1627487-2013-13520 & 1627487-2013-13521. THE PT HAS 3 LEADS FROM DIFFERENT LOT NUMBERS, REPORTING ON ALL LEADS. IT WAS REPORTED DURING A POSTOPERATIVE APPOINTMENT, THE PT LOVED HIS STIMULATION, HOWEVER, THE PT'S MOTHER STATED THERE HAD BEEN A LITTLE DRAINAGE FROM HER SON'S IPG INCISION SITE. THE PT DID NOT HAVE A FEVER. IT WAS NOTED THE PT WAS A SLOW HEALER FROM HIS TRIAL PROCEDURE, IT TOOK APPROXIMATELY 2 MONTHS TO HEAL. THE NURSE PRACTITIONER REGLUED THE INCISION AND PRESCRIBED A STRONGER ANTIBIOTIC. FOLLOW-UP INFORMATION IDENTIFIED THE PT WAS HEALING SLOWLY, BUT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139546 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 3935765

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL: 3788