BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 4733535 · Received April 28, 2015

    Report

    Report Number
    1627487-2015-15145
    Event Type
    Injury
    Date Received
    April 28, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 6, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE PATIENT HAS 4 LEADS (3 FROM LOT 4174030 AND 1 FROM LOT 3895342) IMPLANTED AS PART OF HER PNS (OFF-LABEL) SYSTEM. DEVICE 1 OF 2, REFERENCE MFR REPORT: 1627487-2015-15146. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT THE PERIPHERAL LEAD SITE. SURGICAL INTERVENTION WAS UNDERTAKEN AND 2 PERIPHERAL LEADS WERE EXPLANTED. CULTURES WERE TAKEN HOWEVER, THE RESULTS HAVE NOT YET BEEN PROVIDED. IT IS UNKNOWN WHICH 2 LEADS WERE EXPLANTED; THEREFORE ALL POSSIBLE LOTS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279726 QUATTRODE LEAD WIDE SPACED, 90 CM SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3169 3895342

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other MODEL 3789, SCS IPG| MODEL 3341 (2), SCS EXTENSION