BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7439776 · Received April 18, 2018

    Report

    Report Number
    3004209178-2018-08252
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    April 12, 2018
    Report Date
    April 30, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708640 (B)(4) IMPLANTED: (B)(6)2016 PRODUCT TYPE EXTENSION PRODUCT ID 3387-40 LOT# 0211338700 IMPLANTED: (B)(6)2016 . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    UPDATED AND CORRECTED. (B)(4) DOES NOT APPLY. (B)(4) IS THE MORE APPLICABLE CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THAT A CHEST X-RAY TAKEN IN (B)(6)2016 SHOWED THE BATTERY WAS FLIPPED. AS A RESULT THE LEFT EXTENSION APPEARS TO HAVE DESCENDED AND HAS A HARD KINK IN IT. ON DATE NOTIFIED THE SYSTEM WAS INTERROGATED WHICH SHOWED THAT THE BATTERY WAS ON WITH THERAPY AT 0% AND AN OUT OF RANGE (OOR) MESSAGE SEEN. IMPEDANCE TESTS SHOWED AN OPEN CIRCUIT ON THE LEFT LEAD BUT NOT ON THE PROGRAMMED CONTACTS. THE VALUES WERE AS FOLLOWS: C <(>&<)> 2 = 24471, 1 <(>&<)> 2 = 24471, 0 <(>&<)> 2 = 23373, 2 <(>&<)> 3 = 25059. THE PATIENT HAD NO APPARENT LOSS OF THERAPY WITH THERAPY IMPEDANCES WITHIN NORMAL RANGE. THE IMPLANT WAS SWITCHED OFF AND BACK ON WITH THE SYSTEM THEN REPORTING ON AND THERAPY AT 100%. WHEN THERAPY WAS TURNED BACK ON THE PATIENT LOOKED AS IF THEY WERE IN AN "OFF" STATE AND THEIR PARKINSON'S SYMPTOMS RETURNED AND THEM FEELING LIKE THEY WERE "OFF." THIS LASTED FOR APPROXIMATELY 4 MINUTES UNTIL IT RESOLVED WITH THE PATIENT FEELING LIKE THEY WERE BACK "ON." ON (B)(6) THE PATIENT WAS HAVING A SHOCKING SENSATION BEHIND THE RIGHT EYE WITH A LEFT ARM SPASM. THEY WERE ALSO PLACED ON AN ANTI-EPILEPTIC FOR SEIZURE ACTIVITY AT THIS TIME. IT WAS LATER NOTED THAT THE DATE WAS NOT CORRECTLY SET ON THE IMPLANT SO THE USAGE COULD NOT BE RELIED UPON. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REP WAS CONFUSED AS THE PATIENT'S SYMPTOMS ARE ON THE OPPOSITE SIDE FROM THE OPEN, MEANING THE LEFT LEAD IS SHOWING THE OPEN CIRCUIT WHILE THE SYMPTOMS ARE ON THE RIGHT BRAIN, BODY. THE OOR OCCURRED WHEN THE PATIENT WAS CHECKING THEIR DEVICE AND REMAINED FOR A NUMBER OF DAYS PRIOR TO THEM BEING SEEN BY THE REP. A WARNING WAS ALSO SEEN BY THE REP WHEN THEY ATTEMPTED TO INTERROGATE. THE PATIENT HAS ALSO REPORTED ONGOING SPASMS SINCE THE OOR HAS BEEN CLEARED DESPITE MEDICATION INCREASE. THE REP IS CONCERNED THE DEVICE IS CAUSING THE ISSUES. THE HIGH IMPEDANCE ISSUE REMAINS UNRESOLVED. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DISEASE. IT WAS REPORTED THAT THE PATIENT HAD AN OUT OF REGULATION (OOR) MESSAGE AND FELT AN ELECTRICAL SHOCK BEHIND THEIR RIGHT EYE, ALONG WITH A SPASM IN THEIR LEFT HAND. THEIR SYSTEM WAS INTERROGATED WITH AN N¿VISION® CLINICIAN PROGRAMMER. THE DEVICE WAS ON AND THERAPY 0%. THERE WAS AN OPEN IMPEDANCE ON THEIR LEFT LEAD, NOT ON PROGRAMMED ELECTRODES. THEY TURNED THE INS OFF AND BACK ON, THEN REPORTED ON AND THERAPY 100%. THE PATIENT FELT LIKE THEIR THERAPY WAS OFF AND HAD SYMPTOMS RETURN FOR APPROXIMATELY 4 MINUTES - THEN RESOLVED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283991 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR