BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4289796 · Received December 2, 2014

    Report

    Report Number
    3004209178-2014-22359
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    October 7, 2014
    Report Date
    November 14, 2014
    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

    PRODUCT ANALYSIS #(B)(4):THE INS PASSED FUNCTIONAL TESTING INCLUDING IMPEDANCE TESTING IN SALINE. AS RECEIVED, THE INS WAS PROGRAMMED INCORRECTLY FOR THE TYPE OF LEADS AND EXTENSIONS BEING USED. THE LEAD AND EXTENSION INFORMATION STORED IN THE INS STATED THAT TWO MODEL 37083-60 EXTENSIONS AND TWO MODEL 3487A LEADS WERE BEING USED WITH THE INS. THIS REQUIRES THAT A 2X4 LEAD CONFIGURATION BE USED WITH ELECTRODES 0-3 AND 8-11. THE INS WAS PROGRAMMED AS A 2X4 WITH ELECTRODES 0-3 AND 4-7 (SEE THE AN_IR DOCUMENT IN ATTACHMENTS). CONCOMITANT PRODUCTS: PRODUCT ID 3487A-33, LOT # V000574, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3487A, LOT # J0104085V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD; PRODUCT ID 3708360, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3708360, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. (B)(4). UPON RETURN ANALYSIS FOUND THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PROGRAMMED INCORRECTLY. THE INS PASSED FUNCTIONAL TESTING INCLUDING IMPEDANCE TESTING IN SALINE. THE INS PASSED FUNCTIONAL TESTING INCLUDING IMPEDANCE TESTING IN SALINE. THE INS WAS PROGRAMMED INCORRECTLY FOR THE TYPE OF LEADS AND EXTENSIONS BEING USED. THE LEAD AND EXTENSION INFORMATION STORED IN THE INS WOULD HAVE REQUIRED A 2X4 LEAD CONFIGURATION BE USED WITH ELECTRODES 0-3 AND 8-11. THE INS WAS PROGRAMMED AS A 2X4 WITH ELECTRODES 0-3 AND 4-7. THE ELECTRODES OF THE LEADS WERE PLACED IN 0.9% SALINE SOLUTION AND IMPEDANCES WERE TESTED AND NORMAL ON EVERY PAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY, HIGH IMPEDANCES OF >10000 OHMS WERE MEASURED ON THE RIGHT ¿ARRAY¿ IN THE SECOND CHAMBER. PRIOR TO REPLACEMENT SURGERY, THE PREVIOUS INS STIMULATION WITH BOTH LEAD ARRAYS WAS SAID TO BE STRONG AND APPROPRIATE FOR THE PATIENT¿S PAIN TARGET, AND THERE WERE NO COMPLAINTS OR ISSUES VOICED BY THE PATIENT. REPORTS SHOW THAT THE PATIENT¿S PREVIOUS INS HAD REACHED ITS ELECTIVE REPLACEMENT INDICATOR. THE LEADS WERE TESTED BY MOVING THE LEADS INTO CHAMBER 1 OF THE REPLACEMENT INS, AND STIMULATION COVERAGE WAS APPROPRIATE. THE CHAMBER AND LEAD WERE CLEANED AND THE LEAD WAS RESEATED WITHOUT CHANGE IN IMPEDANCES AND CONDUCTION. IT WAS REPORTED THAT THE PHYSICIAN REQUESTED A SECOND INS BE USED, AND THE FIRST INS WAS NEVER IMPLANTED. THE MANUFACTURER REPRESENTATIVE NOTED THEY DID NOT HAVE A PRINTOUT OF THE PATIENT¿S PROGRAMMING WITH THE ORIGINAL INS, AND INSTEAD USED A SAVED PROGRAMMING SESSION ON THE PHYSICIAN PROGRAMMER AS A TEMPLATE FOR THE REPLACEMENT DEVICE. AFTER OBTAINING A PRINTOUT FROM THE ORIGINAL INS, THE MANUFACTURER REPRESENTATIVE NOTICED THAT THEY HAD BEEN USING THE INCORRECT ELECTRODES IN THE 2X4 LEAD CONFIGURATION FOR THE PATIENT¿S IMPLANTED LEADS AND EXTENSIONS. THE PROGRAMMED LEAD CONFIGURATION WAS CHANGED TO 1X8/1X8 AND NORMAL IMPEDANCES WERE SEEN FOR THE APPROPRIATE ELECTRODES (0-3 AND 8-11), AND HIGH IMPEDANCES WERE SEEN FOR THE NON-EXISTENT ELECTRODES (4-7 AND 12-15) AS EXPECTED. IT WAS REPORTED THAT BOTH LEADS WERE TESTED AND COVERAGE WAS APPROPRIATE. THE MANUFACTURER REPRESENTATIVE STATED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778504 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR