BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD, 3/6MM, 30 CM

    MDR report key: 4362630 · Received December 26, 2014

    Report

    Report Number
    1627487-2014-03786
    Event Type
    Injury
    Date Received
    December 26, 2014
    Date of Event
    November 4, 2014
    Report Date
    December 4, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 1 OF 2 REFERENCE MFR. REPORT: 1627487-2014-03787. THE PATIENT HAS 2 SCS LEADS. PREVIOUSLY, THE PATIENT HAD 2 SCS LEADS FROM LOT 4240095; HOWEVER, DURING A LEAD REVISION PROCEDURE (REFERENCE MFR. REPORT: 1627487-2014-15628), ONE OF THE LEADS WAS EXPLANTED AND REPLACED. IT WAS REPORTED, THE PATIENT IS NO LONGER RECEIVING STIMULATION AS A RESULT OF ONE FRACTURED SCS LEAD AND ONE SCS LEAD NOT PROVIDING STIMULATION EVEN AT MAXIMUM AMPLITUDE. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852009 QUATTRODE LEAD, 3/6MM, 30 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3153 3843024

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other MODEL 1194, SCS ANCHOR| MODEL 3716, SCS IPG| MODEL 3343, SCS EXTENSION