BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3830793 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09588
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    May 5, 2014
    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 Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37601, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 748266, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7436, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748266, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V023165, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V024801, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 64002, LOT # N268789, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ADAPTER; PRODUCT ID 3389S-40, LOT # V063950, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V061739, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 7482A66, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A66, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2014 THAT THERE WERE SOME OUT OF RANGE IMPEDANCES ON THE RIGHT SIDE. THE MEASUREMENT OF UNIPOLAR 4 WAS 6,600 OHMS, 5 WAS 2,400, AND 6 WAS 2,100. THE IMPEDANCES WERE NOT TESTED AT A HIGHER SETTING. THE PATIENT NEEDED A MRI FOR POSSIBLE NEUROLOGICAL ISSUES. THE PATIENT WAS SEEN IN SEPTEMBER OR OCTOBER BY HIS HEALTHCARE PROVIDER (HCP) AND AT THE TIME HE WAS GETTING GREAT THERAPEUTIC BENEFIT. THREE TO FIVE DAYS LATER THE PATIENT STARTED TO HAVE VISION LAPSES, WHICH LASTED A FEW SECONDS, AND OCCURRED EVERY FEW HOURS. THE PATIENT ALSO STARTED TO EXPERIENCE A LOSS OF MUSCLE TONE IN HIS LEGS AFTER VISITING THE HCP, DESCRIBING IT AS ¿GIVING OUT.¿ THIS OCCURRED A FEW TIMES A DAY. THE PATIENT WAS SEEN BY OTHER PHYSICIANS AND THEY RULED OUT SEIZURES. IN DECEMBER THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF COMPLETELY AND REMAINED OFF AT THE TIME OF THE REPORT. THE PATIENT STILL HAD SOME VISION DIFFERENCES AND HIS LEGS STILL GAVE OUT, BUT HE WAS NOT FALLING AS OFTEN. THE REPORTER NOTED THAT THE PATIENT WOULD BE HAVING A BATTERY REPLACEMENT DUE TO IT BEING NEAR END OF LIFE (EOL) FROM NORMAL DEPLETION. FIVE DAYS LATER IT WAS REPORTED THAT THE PATIENT WAS DOING FINE AND HE WAS SCHEDULED FOR A BATTERY REPLACEMENT ¿IN A FEW WEEKS.¿ THE FOLLOWING DAY IT WAS REPORTED THAT THERE WERE OUT OF RANGE IMPEDANCES ON THE LEFT SIDE. HOWEVER, IT WAS NOTED THAT TYPICAL NUMBERING SUGGESTED THE IMPEDANCES WERE FOR THE RIGHT SIDE. THUS, IT WAS UNCLEAR WHICH SIDE HAD OUT OF RANGE IMPEDANCES. REFER TO MANUFACTURING REPORT #3004209178-2014-09587 AS THE PATIENT HAD TWO ACTIVE IMPLANTS AND IT WAS UNCLEAR WHICH THE CAUSE OF THE ISSUE WAS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING THE BATTERY CHANGE OUT ON THE DAY OF THE REPORT DUE TO NORMAL BATTERY DEPLETION. THE PATIENT HAD NOT HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNED ON FOR THE PAST SIX MONTHS DUE TO SIDE EFFECTS. SINCE HAVING THE INS OFF, THE PATIENT CONTINUED TO EXPERIENCE DECREASED MUSCLE TONE AND VISION, SO HE WAS SCHEDULED FOR A MRI. THE PHYSICIAN DID NOT THINK THE SYMPTOMS WERE DEVICE RELATED, BUT DID NOT KNOW WHAT WAS CAUSING THEM. IT WAS NOTED THAT THE RIGHT SIDE INS IMPEDANCES WERE SLIGHTLY HIGHER THAN NORMAL. COMBINATION CASE AND 4, 4 AND 6, AND 4 AND 7 WERE SHOWING 3,900 TO 4,300 OHMS. THE PREVIOUS IMPEDANCES ON THESE COMBINATIONS ON (B)(6) 2014 WERE 6,600, 7,876, AND 7,406 OHMS RESPECTIVELY. ON (B)(6) 2014 THE IMPEDANCES WERE 3,923, 3,574, AND MID-4,000 TO 5,000 OHMS RESPECTIVELY. THE INS WAS NOT GOING TO BE TURNED ON AFTER REPLACEMENT AS THE PATIENT WAS GOING TO SEE THE NEUROLOGIST FOR PROGRAMMING. FOUR DAYS LATER IT WAS REPORTED THAT EVERYTHING WENT WELL AFTER TROUBLESHOOTING. THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307623 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention