BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, DUAL 4 CHANNEL 60CM

    MDR report key: 5780697 · Received July 9, 2016

    Report

    Report Number
    1627487-2016-03535
    Event Type
    Injury
    Date Received
    July 9, 2016
    Report Date
    August 18, 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

    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

    (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 5 OF 5. REFERENCE MFR. REPORTS: 1627487-2016-003463, 1627487-2016-03532, 1627487-2016-03533 & 1627487-2016-03534. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE PATIENT'S ENTIRE SCS SYSTEM WAS EXPLANTED AND REPLACED. THE ISSUE RESOLVED WITH THE SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    DEVICE 5 OF 5. REFERENCE MFR. REPORTS: 1627487-2016-003463, 1627487-2016-03532, 1627487-2016-03533 & 1627487-2016-03534. THE PATIENT HAS 2 OCCIPITAL PNS LEADS AND 2 SUPRA-ORBITAL PNS LEADS. ADDITIONALLY, THE PATIENT HAS 2 SCS EXTENSIONS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT EXPERIENCES OVERSTIMULATION "UP AND DOWN" HER BACK WHERE THE SCS LEADS AND SCS EXTENSIONS ARE LOCATED. AS A RESULT, THE PATIENT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE. IT WAS ALSO NOTED THAT DURING THE SURGICAL INTERVENTION, THE PHYSICIAN PLANS TO RELOCATE THE SCS IPG TO FACILITATE NOT HAVING SCS EXTENSIONS IN THE PATIENT BACK. THERE ARE NO ALLEGATIONS AGAINST THE DEVICE.

    Description of Event or Problem · 1

    DEVICE 5 OF 5. REFERENCE MFR. REPORTS: 1627487-2016-003463, 1627487-2016-03532, 1627487-2016-03533 AND 1627487-2016-03534.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434503 EXTENSION, DUAL 4 CHANNEL 60CM SCS EXTENSION GZF ST. JUDE MEDICAL - NEUROMODULATION 3346 4559061

    Patients

    Seq Age Sex Outcome Treatment
    1 Other