BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3833751 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09665
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97714, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 97714, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE :EXTENSION. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES WITH READINGS OF >40,000 OHMS. IT WAS STATED THAT THE EXTENSION WOULD NOT FIT INTO THE BATTERY PORT. IT WAS FURTHER STATED THAT THE EXTENSION WAS REPLACED AND STILL WOULD NOT FIT CORRECTLY. IT WAS NOTED THAT THE BATTERY WAS THEN REPLACED, BUT THERE WERE STILL HIGH IMPEDANCES IN RELATION TO ELECTRODE ZERO. IT WAS STATED THAT THE BATTERY WAS IMPLANTED AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. IT WAS NOTED THAT THE EVENT OCCURRED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT PROCEDURE, THE IMPEDANCES WERE FOUND TO BE HIGH. IT WAS STATED THAT A 20CM EXTENSION WAS THEN ADDED ON TO THE LEFT SIDE, BUT IMPEDANCES WERE STILL HIGH. IT WAS FURTHER STATED THAT THE EXTENSIONS ON THE LEFT SIDE WERE DIFFICULT TO CONNECT TOGETHER. IT WAS NOTED THAT THE RIGHT LEAD WAS ¿VERY EASY TO MOVE IN.¿ IT WAS STATED THAT THE RIGHT AND LEFT SIDE LEADS AND EXTENSIONS WERE TESTED SEPARATELY IN THE MULTI-LEAD TRIALING CABLE (MLTC) AND SHOWED IN-RANGE IMPEDANCES. IT WAS NOTED THAT THEY HAD TRIED ¿SWITCHING TAILS¿ IN THE INS, BUT THAT DID NOT RESOLVE THE ISSUE. IT WAS NOTED THAT THE IMPEDANCES HAD BEEN TESTED PRIOR TO THE REPLACEMENT WAS HAD BEEN FINE. IT WAS NOTED THAT REINSERTING THE DEVICES MULTIPLE TIMES. IT WAS STATED THAT WHEN TRYING TO INSERT THE LEFT EXTENSION INTO THE INS THEY GET A LOT OF RESISTANCE. IT WAS NOTED THAT THE HIGH IMPEDANCES WERE SUSPECTED TO HAVE BEEN CAUSED BY DAMAGE TO THE EXTENSION. IT WAS FURTHER NOTED THAT THERE WAS NO VISIBLE DAMAGE TO THE EXTENSION. IT WAS STATED THAT WHEN THE LEFT EXTENSION WAS TESTED IN THE MLTC, IMPEDANCES OF LESS THAN 2000 WERE SEEN. IT WAS NOTED THAT THE IMPEDANCES WERE FINE WHEN THE ORIGINAL EXTENSION WOULD BE TESTED. IT WAS STATED THAT THERE WERE NO ISSUES WITH THE SET SCREW ON THE INS. IT WAS NOTED THAT AFTER ADDING THE SECOND EXTENSION ONTO THE FIRST EXTENSION, THERE WAS STILL A LOT OF RESISTANCE IN THE INS HEADER BLOCK. ADDITIONAL INFORMATION RECEIVED REPORTED THAT BOTH THE EXTENSION AND THE INS HAD BEEN REPLACED. IT WAS NOTED THAT IMPEDANCES WITH REFERENCE TO 0, 2, 3, AND 7 WERE OUT OF RANGE. AFTER INCREASING THE VOLTAGE TO 3V, THE IMPEDANCE VALUES FOR 0, 2, AND 3 WERE STILL OUT OF RANGE. WITH REFERENCE TO 4, 8-15 WERE IN RANGE. IT WAS NOTED THAT THE INS WAS IN THE POCKET AND THE SET SCREWS WERE TIGHTENED. IT WAS NOTED THAT THE 0-7 EXTENSION WAS TESTED IN THE MLTC AND NOTHING HAD BEEN OUT OF RANGE. AFTER REINSERTING ONLY THE 0-7 EXTENSION INTO THE INS, OUT OF RANGE IMPEDANCES WERE SEEN FOR 9, 10, 12, 14, AND 15. IT WAS NOTED THAT THE HIGH IMPEDANCES WERE THEN SEEN ON THE 8-15 LEAD BECAUSE THE ELECTRODE NUMBERS HAD BEEN CHANGED ON THE CLINICIAN PROGRAMMER. THE 8-15 LEAD WAS THEN REINSERTED INTO THE HEADER BLOCK AND THE HIGH IMPEDANCES REMAINED THE SAME. IT WAS NOTED THAT THERE WAS NO FLUID IN THE INS OR THE POCKET AREA. NO NEW INFORMATION RECEIVED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS THOUGHT THAT THE END OF THE EXTENSION HAD BECOME DAMAGED WHEN THE PHYSICIAN TOOK IT OUT OF THE ORIGINAL BATTERY AND THAT THIS IS WHAT CAUSED THE HIGH IMPEDANCES. NO NEW INFORMATION. NO NEW INFORMATION.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310240 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR