BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3821517 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09289
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4). FINAL DEVICE ANALYSIS REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL IMPLANT, IT WAS THOUGHT THAT THE STIMULATOR WAS DAMAGED. WHILE TRYING TO IMPLANT THE STIMULATOR (INS), BLOOD AND FLUID WERE SEEN IN THE UPPER PART OF THE HEADER BLOCK. PRIOR TO CONNECTING THE LEAD TO THE INS, IMPEDANCES WERE NORMAL. WHEN CONNECTED TO THE INS, IMPEDANCES WERE HIGH ON 3 CONTACTS. THE LEAD WAS REMOVED, WIPED DOWN AND RECONNECTED. ALL IMPEDANCES WERE THEN HIGH. THE LEAD WAS TESTED ALONE WITH A MULTI LEAD TRIALING CABLE AND IMPEDANCES WERE NORMAL. THUS, THEY DECIDED TO CHANGE OUT THE INS. IT WAS FURTHER STATED THAT THE PHYSICIAN FELT THE INS WAS DEFECTIVE AND DID NOT FEEL COMFORTABLE USING IT. IN ADDITION, THERE WERE NO INJURIES TO THE PATIENT AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299821 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR