BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 5895192 · Received August 22, 2016

    Report

    Report Number
    3004209178-2016-17405
    Event Type
    Malfunction
    Date Received
    August 22, 2016
    Report Date
    November 2, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR DEMENTIA NO LONGER APPLIES. 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

    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

    FOLLOW-UP INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER. IT WAS DETERMINED THAT THE REPORTED DEMENTIA WAS NOT DUE TO DEVICE OR THERAPY.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THE FOLLOWING IMPEDANCE MEASURES AT 1.5 V 210 USEC 30 HZ LEFT STN C0 C1 1395 C>4000 C3>4000 1395 02>4000 03>4000 12 1395 13>4000. THE RIGHT STN WERE AS FOLLOWS C4 1395 C5 690 C6 690 C7 1395 45 1395 47 1395. TESTING AT 3.9 V 210USEC 30HZ FOUND LEFT STN C0 693 C1 1406 C2 693 C>4000 01 931 02 693 03>4000 12 1406 13>4000 23>4000. THE RIGHT STN IMPEDANCE VALUES AT 3.0 V 210 USEC 30 HZ WERE AS FOLLOWING C4 931 C5 693 C6 893 C7 931 45 140646 1406 47 1406. IT WAS UNKNOWN IF THE PATIENT HAS HAD ANY RECENT MEDICAL TESTS OR EMI EXPOSURE. IT WAS POSSIBLE AS THE PATIENT HAD HIP SURGERY RECENTLY. IT WAS NOTED THERE IS A GREATER THAN 1 -2K OHM DIFFERENCE COMPARED TO HISTORICAL IMPEDANCE VALUES. IT WAS NOTED THE PATIENT HAD A LOSS OF THERAPY, THE DATE WAS UNKNOWN. THE HCP NOTED THEY HAVE NOT SEEN THE PATIENT IN 2 YEARS, THE PATIENT IS CURRENTLY PROGRAMMED ON C<(>&<)>0 1.0 V 90USEC 90 HZ WITH A BATTERY VOLTAGE AT 2.74 V. THE HCP NOTED THE IMPEDANCE VALUES AREN¿T OPTIMAL, BUT IF THEY DO NOT COMPARE AGAINST PREVIOUS IMPEDANCES IT IS DIFFICULT TO SAY IF THERE IS A PRESSING ISSUE WITH THE SYSTEM OR IF IT IS OTHER FACTORS THAT ARE CONTRIBUTING TO PATIENT¿S SITUATION. IT WAS ALSO NOTED THE PATIENT HAS A URINARY TRACT INFECTION. ADDITIONAL INFORMATION FROM THE HCP REPORTED IMPEDANCE CHECKS WERE PERFORMED AS A DIAGNOSTICS RELATED TO THE PATIENT LOSS OF THERAPY AND IMPEDANCE ISSUES. THE IMPEDANCE CHECK FOUND IMPEDANCES WERE WITHIN NORMAL LIMITS, C+0= 690 C+5=690. THE IMPEDANCES WERE RECHECKED AND FOUND C+0=691 AND C+5=693. THE HCP NOTED THE PATIENT WAS EVALUATED BY THEIR PRIMARY CARE PHYSICIAN AND GIVE ANTIBIOTICS FOR THE URINARY TRACT INFECTION. THE HCP WAS ALSO NOTED THE URINARY TRACT INFECTION WAS NOT RELATED TO THE DEVICE OR THERAPY. IT WAS NOTED THE PATIENT HAS HAD IMPROVEMENT IS THE LOSS OF THERAPY, URINARY TRACT INFECTION, AND IMPEDANCE ISSUES. THE LOSS OF THERAPY, URINARY TRACT INFECTION AND IMPEDANCE ISSUES WERE ALL RESOLVED AT THE TIME OF THIS REPORT. IT WAS ALSO NOTED THE PATIENT HAS DEMENTIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546544 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Other