BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 5913839 · Received August 30, 2016

    Report

    Report Number
    1627487-2016-04477
    Event Type
    Injury
    Date Received
    August 30, 2016
    Date of Event
    August 4, 2016
    Report Date
    August 4, 2016
    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). 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. (B)(4).

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2016-04476. THE PATIENT RECEIVED TWO MODEL 3166 LEADS FROM LOT NUMBER 3831998 AND TWO MODEL 3169 LEADS FROM LOT 3788252. IT IS UNDETERMINED WHICH OF THE LEADS WAS REVISED. ALL POSSIBLE DEVICES ARE BEING REPORTED. IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REVISED ONE OF THE SCS LEADS DUE TO DISCOMFORT. THE PATIENT STATED SHE FELT DISCOMFORT ON HER RIGHT SIDE OF THE HEAD WHEN SHE APPLIED PRESSURE. THE PHYSICIAN SUSPECTED THERE WAS A SUPERFICIAL SUTURE WHICH COULD HAVE BEEN BOTHERING THE PATIENT. FOLLOW UP IDENTIFIED THE DISCOMFORT HAS RESOLVED AND THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564747 QUATTRODE LEAD WIDE SPACED, 90 CM SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3169 3788252

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other MODEL 3346 (X2), SCS EXTENSION