BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3976757 · Received August 4, 2014

    Report

    Report Number
    3004209178-2014-13898
    Event Type
    Injury
    Date Received
    August 4, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7427, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3998, LOT# LA7899, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD; PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION; PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD/EXTENSION WERE TESTED INTRAOPERATIVE AND THE IMPEDANCES WERE WITHIN NORMAL RANGE. THE PREVIOUS BATTERY WAS REPLACED AND THE NEW BATTERY ALSO SHOWED IMPEDANCES WITHIN NORMAL RANGE. POST-OPERATIVE PROGRAMMING WAS FINE. THE LEAD AND EXTENSIONS WERE NOT CHANGED. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT SINCE (B)(6). THEIR PREVIOUS BATTERY WAS REPLACED ON (B)(6). THEY ALSO HAD A POST-OP APPOINTMENT. THE PATIENT HAD NO STIMULATION SENSATION UP TO 10.5V. IT WAS THOUGHT THAT THE PATIENT FELT STIMULATION POST-OP ON (B)(6) BUT THEY THOUGHT THAT WAS DUE TO ANESTHESIA AND PAIN MEDICATION AT THE TIME OF THE REPORT. THE PATIENT HAD NOT FELT STIMULATION SINCE (B)(6) AND THAT WAS A SUDDEN CHANGE. THE IMPEDANCES WERE READING >4000 OHMS ON SOME COMBINATIONS. THE 01 PAIR WAS IN THE 2000 OHM RANGE. THE OTHER COMBINATIONS WERE 03 = 4300, 12 = 2598, 13 = 4200, 23 = 2975, 45 = 2071, 46 = 3646, 47 = 4386, 56 = 2570, 57 = 4055, 67 = 2868 OHMS. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NO LONGER HAD PAIN RELIEF FROM THE STIMULATION. REPROGRAMMING WAS ATTEMPTED BUT WAS UNSUCCESSFUL. MORE THAN 20 DIFFERENT CONFIGURATIONS WERE TRIED ON ALL PARTS OF THE LEAD BUT NONE ELICITED THERAPEUTIC STIMULATION. THEY ALSO ATTEMPTED TO PROGRAM BETWEEN ELECTRODES WITH THE LOWEST IMPEDANCES. IMPEDANCES FOR ELECTRODES 4 AND 5 WERE GREATER THAN 10,000 OHMS AT 0.7V. IMPEDANCES WERE LESS THAN 10,000 OHMS FOR ALL ELECTRODES AT 1.5V BUT MANY WERE ELEVATED AND HIGHER THAN 2,000. THE PATIENT DID NOT FEEL STIMULATION UP TO 10.5 IN MOST OF THE SCENARIOS. IN ALL SCENARIOS THE STIMULATION WAS NOT STRONG OR THERAPEUTIC UP TO 10.5V. THE PATIENT WAS SCHEDULED FOR A LEAD REPLACEMENT ON (B)(6) 2014. THE CAUSE OF THE EVENT WAS UNKNOWN. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEELING COVERAGE WHERE THEY NEEDED IT AND WERE PLEASED WITH THE OUTCOME AFTER THE OPERATION. THERE WERE NO DEVICE MALFUNCTIONS SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452723 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention