BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, DUAL 4 CHANNEL 60CM

    MDR report key: 6171908 · Received December 13, 2016

    Report

    Report Number
    1627487-2016-06398
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 19, 2016
    Report Date
    June 5, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT OF INFECTION CANNOT BE ANALYZED VIA LABORATORY TESTING. 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.

    Additional Manufacturer Narrative · 1

    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 4 OF 4. REFERENCE MFR REPORT 1627487-2016-06395, 1627487-2016-06396, 1627487-2016-06397. FOLLOW UP REVEALED THAT THE PATIENT'S INFECTION HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    DEVICE 4 OF 4. REFERENCE MFR REPORT #1627487-2016-06395, 1627487-2016-06396, 1627487-2016-06397.

    Description of Event or Problem · 1

    DEVICE 4 OF 4. REFERENCE MFR REPORT #1627487-2016-06395, 1627487-2016-06396, 1627487-2016-06397. IT WAS REPORTED THE PATIENT REPORTED TO THE EMERGENCY ROOM DUE TO A SUSPECTED INFECTION. THE PATIENT'S INCISION SITES WERE BULGING AND HAD PUSTULES AND DISCHARGE AT THE OCCIPITAL (OFF LABEL PLACEMENT) LEAD INCISION AND AN EXTENSION INCISION. THE PATIENT WAS INSTRUCTED TO CONTINUE TAKING THE ORAL ANTIBIOTICS GIVEN FOLLOWING IN THE SURGERY. ADDITIONALLY, THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS IN THE EMERGENCY ROOM. IT WAS ALSO REPORTED THE PHYSICIAN DETERMINED THE PATIENT DID NOT HAVE AN INFECTION.

    Description of Event or Problem · 1

    DEVICE 4 OF 4. REFERENCE MFR REPORT 1627487-2016-06395, 1627487-2016-06396, 1627487-2016-06397. FOLLOW UP REVEALED THE PATIENT WAS SEEN BY THE PHYSICIAN ASSISTANT WHO NOTED THE PATIENT STILL HAS NO UNUSUAL BACTERIAL OR SIGNS OF INFECTION, BUT THE OPENINGS HAVE FAILED TO COMPLETELY CLOSE AND THE LEAD IS STILL VISIBLE. THE PHYSICIAN SURGICALLY CLEANED THE WOUNDS ON (B)(6) 2017. THE PATIENT WAS SEEN ON (B)(6) 2017 AND THE PHYSICIAN FOUND THAT ALL WOUNDS LOOK GOOD, CLEAN AND CLOSED. PATIENT IS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    DEVICE 4 OF 4. REFERENCE MFR REPORT 1627487-2016-06395, 1627487-2016-06396, 1627487-2016-06397. IT WAS REPORTED THE PATIENT'S SUTURE SITES HAD NOT HEALED PROPERLY AND THE AREA WAS INFECTED. THE DEVICES WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822142 EXTENSION, DUAL 4 CHANNEL 60CM SCS EXTENSION GZF ST. JUDE MEDICAL - NEUROMODULATION 3346 5459839

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other