BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 1892060 · Received October 26, 2010

    Report

    Report Number
    1627487-2010-03054
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 SPECIFICATIONS AND NO ANOMALIES 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 REPORTS: 1627487-2010-03053 AND 1627487-2010-03055. THE PT RECEIVED A NEUROSTIMULATION SYS, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS, AS PART OF A CLINICAL STUDY FOR THE TREATMENT OF MIGRAINES. THE PT EXITED THE CLINICAL STUDY IN (B)(6) 2010. IT WAS REPORTED THEY NOTED SOME SWELLING BEHIND ONE OF HER EARS. EXAMINATION BY THE PT'S PHYSICIAN RULED THE SWELLING TO BE A SEBACEOUS CYST; HOWEVER, A SECOND EXAMINATION WAS PERFORMED BY THE PT'S PLASTIC SURGEON. THE SURGEON SUSPECTED A DEEP INFECTION. AS A RESULT OF THE SUGGESTED INFECTION, THE PT'S IMPLANTING PHYSICIAN SCHEDULED AN EXPLORATORY SURGERY. UPON REMOVING THE CYST, THE PHYSICIAN COULD NOT DEFINITIVELY RULE OUT AN INFECTION. THE NEUROSTIMULATION SYS WAS EXPLANTED AND NOT REPLACED. BOTH INTERNAL AND EXTERNAL CULTURES WERE TAKEN; THE RESULTS OF WHICH WERE NOT IMMEDIATELY AVAILABLE. IT IS UNK IF THE EXPLANTED PRODUCTS WILL BE RETURNED FOR ANALYSIS. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3156 174661

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention