BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 30 CM

    MDR report key: 6214852 · Received December 29, 2016

    Report

    Report Number
    1627487-2016-06661
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 9, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    P010032
    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.

    Description of Event or Problem · 1

    DEVICE 2 OF 3. REFERENCE MFR REPORT#1627487-2016-06662. REFERENCE MFR REPORT#1627487-2016-06660. THE PATIENT RECEIVED TWO LEADS (MODEL 3146) WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT RECEIVED 4 QUATTRODE LEADS(OFF LABEL USE). REPORTEDLY, THERAPY BECAME INEFFECTIVE AND IT WAS LATER DISCOVERED THE LEADS HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH TIME THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864748 QUATTRODE LEAD WIDE SPACED, 30 CM SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3163 4591310

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other MODEL 3341(2), SCS EXTENSION| MODEL 3688, SCS IPG