BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 6846900 · Received September 6, 2017

    Report

    Report Number
    1627487-2017-04947
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    August 15, 2016
    Report Date
    October 31, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ST. JUDE MEDICAL 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.

    Additional Manufacturer Narrative · 1

    PROCODE: GZF.

    Description of Event or Problem · 1

    DEVICE #3 OF 3: REFERENCE MFR. REPORT: 1627487-2017-04945 AND 1627487-2017-04946. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2017 WHERE THE ENTIRE SCS SYSTEM WAS EXPLANTED. THE PATIENT IS HEALING WELL. ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    DEVICE #3 OF 3: REFERENCE MFR. REPORT: 1627487-2017-04945 AND 1627487-2017-04946. IT WAS REPORTED THE PATIENT IS NO LONGER RECEIVING STIMULATION. THE ISSUE BEGAN APPROXIMATELY ONE YEAR AGO. REPROGRAMMING INITIALLY RESOLVES THE ISSUE BUT WITHIN SECONDS THE STIMULATION GOES AWAY. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    DEVICE #3 OF 4: REFERENCE MFR. REPORT: 1627487-2017-04945, 1627487-2017-04946 AND 16272487-2017-06160. FOLLOW UP INFORMATION IDENTIFIED AN ADDITIONAL LEAD WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. REVIEW OF THE MANUFACTURER DATA BASE INDICATED TWO LEADS WERE DOCUMENTED AS EXPLANTED IN 2015 (REFERENCE MFR. REPORT: 1627487-2015-07416 AND 1627487-2015-07417) HOWEVER ONLY ONE LEAD WAS EXPLANTED IN 2015 AND MODEL 3169 LN# 4403830 WAS EXPLANTED (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626201 QUATTRODE LEAD WIDE SPACED, 90 CM PNS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3169 4920461

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other