BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 6096974 · Received November 11, 2016

    Report

    Report Number
    1627487-2016-05887
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    August 26, 2016
    Report Date
    December 16, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 3 OF 6: REFERENCE MFR REPORT: 1627487-2016-05885, REFERENCE MFR REPORT: 1627487-2016-05886, REFERENCE MFR REPORT: 1627487-2016-05888, REFERENCE MFR REPORT: 1627487-2016-05889, REFERENCE MFR REPORT: 1627487-2016-05890. THE PATIENT HAS 2 EXTENSIONS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT LOST STIMULATION COVERAGE IN THE TARGETED AREAS OF NECK AND SHOULDERS AND IS EXPERIENCING STIMULATION LIKE SENSATION AT THE IPG POCKET SITE. DIAGNOSTICS SHOWED LOW IMPEDANCES AND X-RAYS INDICATE THE PERIPHERAL LEADS HAVE COILED AROUND IN THE IPG POCKET. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    DEVICE 3 OF 6. REFERENCE MFR REPORT: 1627487-2016-05885. REFERENCE MFR REPORT: 1627487-2016-05886. REFERENCE MFR REPORT: 1627487-2016-05888. REFERENCE MFR. REPORT 1627487-2016-05889. REFERENCE MFR. REPORT 1627487-2016-05890. FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH TIME THE ENTIRE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748399 QUATTRODE LEAD WIDE SPACED, 90 CM PNS GZF ST. JUDE MEDICAL - NEUROMODULATION 3169 5241219

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other