BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3202010 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11191
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3387040, LOT# V008951, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387-40, LOT# J0230952V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION; PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALY. THE BATTERY WAS NORMAL END OF LIFE AND THERE WAS NO TELEMETRY/OUTPUT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387040, LOT# V008951, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# J0230952V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GOING TO HAVE REPLACEMENT SURGERY FOR THE IMPLANTABLE NEUROSTIMULATOR¿S (INS¿S) DUE TO DEPLETION FASTER THAN EXPECTED. IT WAS NOTED THAT THIS COULD BE DUE TO HIGH PARAMETERS AND SETTINGS. THE TWO DEVICES HAD BEEN IMPLANTED TWO MONTHS PRIOR TO (B)(6) 2013 AND THE PATIENT HAD ALREADY RUN THEM DOWN. THE MANUFACTURING REPRESENTATIVE WAS MEETING WITH THE HEALTHCARE PROFESSIONAL (HCP) TOMORROW, (B)(6) 2013 FOR THE REPLACEMENT PROCEDURE. IT WAS CONFIRMED THAT THE TWO PRIMARY CELL BATTERIES WERE REPLACED WITH ONE RECHARGEABLE BATTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) ONE OF THE PATIENT¿S LEFT SIDE IMPLANTABLE NEUROSTIMULATORS (INS) WAS SHOWING THE ELECTIVE REPLACEMENT INDICATOR (ERI) LESS THAN A YEAR AFTER IMPLANT. IT WAS NOTED THE PATIENT HAD HER DEVICES INTERROGATED AND ADJUSTED BY A NEUROLOGIST IN (B)(6) 2013 AND THE BATTERIES WERE STILL SHOWING ¿GOOD¿ AT THAT TIME. THE BATTERIES WERE CHECKED A COUPLE TIMES BETWEEN THAT TIME AND THE TIME OF REPORT AND EVERYTHING WAS ¿COMING OUT FINE¿. THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS WITH INVOLUNTARY MUSCLE MOVEMENTS AND ¿THINGS TO THAT NATURE¿ WHICH BEGAN SLOWLY A MONTH TO A MONTH AND A HALF PRIOR TO REPORT. IT WAS NOTED THAT THE PATIENT¿S HUSBAND WASN¿T SURE IF IT WAS MAYBE HER MEDICATIONS AND IT WAS NOTED THE PATIENT WAS NEARING THE END OF HER BOTOX TREATMENTS. AT THE TIME THE INSS WERE PREVIOUSLY REPLACED ((B)(6) 2012), THE LEADS WERE TESTED AND THEY DID FIND AN OPEN CIRCUIT. WHEN TESTING THE LEADS ¿SEVEN DIFFERENT AND EACH ONE THEY FOUND ONE THAT WAS OPEN¿. IT WAS NOTED THAT IT WAS PROBABLY CALCIFIED TO THE POINT WHERE IT CREATED SUCH A HIGH RESISTANCE IN THE PATIENT¿S BRAIN. THE LEAD WAS NOT REPLACED AT THAT TIME AND THE INFORMATION SUGGESTED THE OPEN CIRCUIT WAS PROGRAMMED AROUND USING OTHER ELECTRODES. IT WAS NOTED THAT NO SHORT CIRCUITS HAD BEEN OBSERVED. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR THE END OF (B)(6) FOR A BATTERY REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE MANUFACTURER REPORT# 3004209178-2013-11188 REGARDING THE PATIENTS RIGHT SIDE IMPLANTABLE NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302264 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention