BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 5562909 · Received April 8, 2016

    Report

    Report Number
    3004209178-2016-07070
    Event Type
    Malfunction
    Date Received
    April 8, 2016
    Report Date
    April 8, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3887-56, LOT# V093185, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3887-56, LOT# V135420, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW OF THE FILE, IT WAS DETERMINED THAT THE STATEMENT "IT WAS REPORTED BY THE PATIENT THAT THEY WERE HAVING PROB LEMS" WAS ADDRESSING A SEPARATE EVENT AND IS NOT APPLICABLE FOR THIS EVENT. IT WAS REMOVED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR OTHER PAIN INDICATIONS - OTHER. IT WAS REPORTED BY THE PATIENT THAT THEY WERE HAVING PROBLEMS. AN IMPEDANCE TEST WAS DONE AT 1.5 V. ALL CONTACT PAIRS SHOWED WITHIN NORMAL EXCEPT THE PAIR 4/6 THAT SHOWED >4,000 OHMS. THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY VOLTAGE WAS 2.94 V AND USED CAPACITY OF <(><<)>20%. THE STIMULATION WAS ON AND THE PATIENT WAS PROGRAMMED AT PROGRAM 1 (0-1-2+5+) WITH 0.20V, 270 PULSE WIDTH, AND 130 HZ AND AT PROGRAM 2 (2+6-7+) WITH 0V, 450 PULSE WIDTH, AND 130 HZ. THE PATIENT WAS NOT REPORTEDLY USING PROGRAM 2. THERE WERE NO PATIENT SYMPTOMS REPORTED. LATER IT WAS REPORTED BY THE PATIENT THAT ONE CONTACT WAS OUT OF RANGE AND HAD HIGH IMPEDANCES BUT THEY HAD BEEN PROGRAMMED AROUND IT. THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED AT THE TIME OF THE REPORT ON (B)(6) 2016. THE PATIENT WAS NOT RECEIVING THERAPY BECAUSE THE PATIENT HAD TURNED THEIR SETTINGS WAY TOO LOW AT 0.2 V. AFTER THE PROGRAMMING SESSION, IT WAS DETERMINED THAT THEIR SETTINGS NEEDED TO BE AROUND 1.23 V. AFTER THE PROGRAMMING, THE PATIENT STATED THAT THEY WERE FEELING STIMULATION BUT THAT THEY WERE HAPPIER ABOUT THE MEDICINES THAT THE HCP HAD PRESCRIBED THEM. THE PATIENT HAD A FOLLOW-UP APPOINTMENT WITH THE HCP FOR RE-EVALUATION OF THE PATIENT'S SITUATION BETWEEN THEIR MEDICATION AND STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217284 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1