BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4293640 · Received December 3, 2014

    Report

    Report Number
    3004209178-2014-22441
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    November 12, 2014
    Report Date
    June 6, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37742, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 399945, LOT # V011864, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 399945, LOT # V011864, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW DETERMINED CONCLUSION CODE (B)(4) NO LONGER APPLIES TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE (REP) WAS WORKING INTRAOPERATIVELY FOR A BATTERY REPLACEMENT DUE TO NORMAL BATTERY DEPLETION, BUT UPON IMPEDANCE CHECK THE VALUES WERE GREATER THAN 10,000 OHMS. THE REP. WAS UNABLE TO CHECK THE IMPEDANCES BEFORE THE SURGERY SO HE WAS NOT AWARE OF THIS ISSUE PRIOR TO THE OPERATION BUT THE PATIENT WAS GETTING GOOD PAIN COVERAGE. THE CONFIGURATION WAS SWITCHED TO 2X8 TO MAKE SURE ALL OF THE PORTS WERE DISPLAYING IMPEDANCE VALUES AND RETURN IMPEDANCES AT THREE VOLTS. THE VALUES OF THAT INCLUDED 0-3 WERE ALL BETWEEN 19,000 AND 40,000. VALUES OF 4-7 BIOPOLES WERE IN THE NORMAL RANGE OF 900-2,000. THE LEAD BODY WAS WIPED WITH DRY GAUZE AND RESEATED. THE IMPEDANCES WERE RERUN FOLLOWING RESEATING THE LEAD AND THE IMPEDANCE VALUES DID NOT IMPROVE. ADDITIONAL INFORMATION RECEIVED FROM THE REP. REPORTED THAT THE PROBLEM WAS NOT ISOLATED TO EITHER THE LEAD OR EXTENSION. THERE WERE NO LEAD FRACTURES NOTED. THE OUTCOME OF THE SURGERY WAS SUCCESSFUL; THE PATIENT WAS RECEIVING EFFECTIVE THERAPY POST-OPERATIVELY AND WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780459 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR