BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3795559 · Received May 7, 2014

    Report

    Report Number
    3004209178-2014-08614
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Report Date
    April 14, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# VA0APD4, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V233444, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37092, LOT# 406840001, PRODUCT TYPE ACCESSORY; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40, LOT# VA0APD4, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V233444, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. IT WAS NOTED THERE WAS A ¿CALL YOUR DOCTOR¿ ICON. IT WAS STATED THERE WAS AN OUT OF REGULATION (OOR) CONDITION. IT WAS NOTED THEY WERE UNABLE TO TURN THE STIMULATION OFF FOR ONE WEEK PRIOR TO REPORT. IT WAS STATED 3 WEEKS PRIOR TO REPORT THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULD NOT TURN OFF. IT WAS NOTED THE PATIENT HAD GONE TO THEIR DOCTOR¿S OFFICE AND THEY THOUGHT THE INS¿ MIGHT HAVE BEEN TOO CLOSE TOGETHER. IT WAS STATED THEY WERE ABOUT 6 INCHES APART. IT WAS FURTHER REPORTED THE OOR MESSAGE WAS SEEN ON THE PATIENT PROGRAMMER. IT WAS NOTED THE OOR MESSAGE WAS INTERMITTENT. IT WAS STATED THE PATIENT DID NOT HAVE ANY ISSUES WITH THE THERAPY AND THEY WERE ABLE TO CLEAR THE MESSAGE. IT WAS NOTED THE MANUFACTURER REPRESENTATIVE DID NOT SEE THE OOR ON THE PATIENT PROGRAMMER. IT WAS NOTED IMPEDANCES WERE WITHIN NORMAL RANGE. IT WAS STATED THE PATIENT FELT MORE TENSION ON THE LEAD WIRE AT THE BACK OF THEIR SKULL BEHIND THE EAR. IT WAS NOTED THEY HAD FELT SOME DIFFERENCE ON THAT LEAD WIRE SINCE A NEW BATTERY WAS PUT IN LAST (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED X-RAYS WERE TAKEN ON THE DAY OF REPORT. IT WAS NOTED NO CLEAR BREAKS WERE SEEN ALTHOUGH THERE WAS SOME LEAD/EXTENSION CONNECTOR BLOCK MIGRATION THAT WAS NOTED. IT WAS STATED THE PATIENT CURRENTLY RECEIVED THERAPY. IT WAS NOTED NO SURGERY HAD BEEN PLANNED AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED AN OUT OF REGULATION (OOR) TWICE. IT WAS NOTED THAT THE PATIENT HAD TWO PRIMARY CELL DEVICES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCES HAD NOT CHANGED MUCH WHEN THEY WERE CHECKED IN VARIOUS NECK AND STRAINED POSITIONS. IT WAS NOTED X-RAYS WERE ORDERED FOR THE HEAD, NECK AND CHEST AND HAD NOT FOUND ANY OBVIOUS BREAKS. THE PATIENT WAS RECEIVING THERAPY AT THE TIME OF REPORT AND THE HEALTHCARE PROFESSIONAL HAD INCREASED THE VOLTAGE WITHOUT ANYTHING ABNORMAL OCCURRING WITH THE DEVICE. ADDITIONAL INFORMATION RECEIVED REPORTED THEY WERE UNABLE TO FIGURE OUT HOW TO SOLVE THE ISSUE OR FIND OUT WHAT CAUSED THE ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE IMPEDANCES APPEARED TO BE NORMAL AND THE SETTINGS DID NOT SEEM CONDUCTIVE TO THE OOR. IT WAS NOTED IT MAY HAVE BEEN RELATED TO THE OLD EXTENSION THAT WAS STILL IMPLANTED. IT WAS STATED AN X-RAY IMAGE HAD BEEN PERFORMED. IT WAS NOTED THE LEFT IMPLANT HAD SHOWED THE OOR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273417 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR