BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4093242 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17106
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 22, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-40, LOT# V561214, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3389S-40, LOT# V561214, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS USING THE CLINICIAN PROGRAMMER AND INTERROGATED THE IMPLANTABLE NEUROSTIMULATOR (INS). WHEN THE HCP HIT THE P BUTTON FOR PROGRAMMING, THE PATIENT FELT A SURGE AND STARTED TREMORING ON THE RIGHT SIDE. THE OBSERVATIONS SHOWED THAT THE STIMULATION WAS OFF. THE HCP HAD TO CHANGE THE BATTERIES IN THE CLINICIAN PROGRAMMER AND WAS STILL SEEING THAT THE STIMULATION WAS OFF. THE HCP CLICKED ON THE INS ICON AND DID NOT SEE THE LIGHTNING BOLT TO INDICATE THE INS WAS ON. THE HCP CHANGED THE BATTERIES IN THE CLINICIAN PROGRAMMER AGAIN, AND THEN THE STIMULATION OFF WAS GONE AND SAW THE DEVICE CLOCK OBSERVATION. THE HCP HAD DIFFICULTY CHANGING THE CLOCK. IT WAS UNKNOWN WHY THE INS WAS OFF. THE BATTERY SHOWED 2.86 VOLTS. THE PATIENT MISPLACED THE PROGRAMMER AND WOULD LOOK FOR IT, AND THE PATIENT WOULD CALL IF HE COULD NOT FIND THE PROGRAMMER. THE HCP NEEDED GLASSES WHILE ON THE PHONE AS SHE HAD A HARD TIME SEEING THE LIGHTNING BOLT ON THE PROGRAMMER INS ICON. THE HCP WAS INSTRUCTED ON HOW TO CHECK AND CHANGE THE DEVICE. THE HCP NOTED THAT THE "MATCH THE NVISION" CHANGED TO THE WRONG TIME. IT STILL SHOWED CHECK DEVICE CLOCK IN THE OBSERVATIONS. THE HCP MANUALLY CHANGED THE TIME BUT WHEN SHE TRIED TO "MATCH NVISION" IT WOULD SHOW THE WRONG TIME. INFORMATION REGARDING PATIENT OUTCOME AND CAUSE OF THE EVENT HAS BEEN REQUESTED WHICH WAS NOT REPORTED REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571346 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR