BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3853039 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10232
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT NO PRINT-OUTS WERE AVAILABLE, BUT ACCORDING TO THE PATIENT, THE IMPEDANCES WERE OK. THE PATIENT DID NOT EXPERIENCE ANY SHOCKING AND THE TESTS DID NOT SHOW ANY ALLERGIES OR INFECTION. ADDITIONALLY, STIMULATION WORKED FINE THE WHOLE TIME AND RECHARGING INTERVAL WAS AS EXPECTED. THE INS WAS RE-ORIENTED IN THE POCKET AND THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POCKET OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS RED AND HOT (¿AND AGING¿). PATIENT SYMPTOMS OF PAIN REDNESS, AND SWELLING AT THE DEVICE POCKET WERE REPORTED. DIAGNOSTICS AND TROUBLESHOOTING THAT WERE PERFORMED INCLUDED IMPEDANCE TESTING ALONG WITH ALLERGY AND INFECTION TESTS. IT WAS NOTED THAT THE INS ¿SHOULD BE RELOCATED¿ ON (B)(6). IT WAS ALSO REPORTED THAT, DEPENDING ON THE SITUATION, THE INS ¿SHOULD BE REPLACED¿ AS THE DOCTOR ASSUMES THE DEVICE WAS HEATING THE POCKET DUE TO A DEFECT. THE CAUSE OF THE PRODUCT ISSUE WAS UNKNOWN. THE PATIENT STATUS AT THE TIME OF REPORT WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333112 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention