BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 5931074 · Received September 6, 2016

    Report

    Report Number
    1627487-2016-04561
    Event Type
    Injury
    Date Received
    September 6, 2016
    Date of Event
    October 8, 2015
    Report Date
    August 15, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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.

    Description of Event or Problem · 1

    DEVICE #2 OF 2: REFERENCE MFR. REPORT: 1627487-2016-04560. THE PATIENT WAS IMPLANTED WITH A PNS SYSTEM THAT INCLUDED FOUR LEADS, TWO MODEL 3163 FROM LOT 3161494 AND TWO MODEL 3166 FROM LOT 3131163. THE PATIENT REPORTS SHE WAS NOT RECEIVING EFFECTIVE STIMULATION AND HENCE SHE UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2015 WHERE THE ENTIRE PNS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581559 QUATTRODE LEAD WIDE SPACED, 60 CM PNS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3166 3131163

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other MODEL 3341(2), SCS EXTENSION| MODEL 3788, SCS IPG