BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3017750 · Received March 22, 2013

    Report

    Report Number
    3004209178-2013-04121
    Event Type
    Injury
    Date Received
    March 22, 2013
    Report Date
    March 12, 2013
    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 Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V020186, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_ADAPTOR_ACC, PRODUCT TYPE ACCESSORY; PRODUCT ID 3387S-40, LOT# V020186, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL #(B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7436, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT # V020186, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "ALL OF A SUDDEN OUT OF THE BLUE" THERE WAS AN OPEN CIRCUIT AT ELECTRODE #1 WHICH WAS THE LEAD THE PATIENT HAD BEEN GETTING THE BEST RESULTS FROM. THE PATIENT WAS ABLE TO BE PROGRAMMED USING ELECTRODE TWO AND HAD SOME BENEFIT JUST FOR A COUPLE DAYS AND THEN GRADUALLY GOT WORSE WITH ALMOST CONTINUAL TREMOR. IT WAS NOTED THAT PREVIOUSLY THE PATIENT HAD EXCELLENT TREMOR CONTROL AT LOW SETTINGS. IT WAS ALSO NOTED IT WAS "REALLY PULLING." IT WAS UNKNOWN WHICH COMPONENT OF THE IMPLANTABLE NEUROSTIMULATOR WAS CAUSING THE ISSUES. THE PATIENT'S PREVIOUS INS HAD BEEN FLIPPING IN THE POCKET WHICH LEAD TO COILED EXTENSIONS AND SHORTED OUT THE TOP THREE CONTACTS. SEE MANUFACTURER REPORT # 3004209178-2010-02459 REGARDING THE PRIOR INS. THE SAME LEAD AND EXTENSION WERE BEING USED WITH THE NEW INS. THE PATIENT WAS ON COUMADIN AND HIS INTERNATIONAL NORMALIZED RATIO (INR) WAS OFF. IT WAS NOTED THE PATIENT WAS "TOO FRAGILE" FOR SURGERY AND HAD A HISTORY OF STROKE AND TRANSIENT ISCHEMIC ATTACK (TIA) AND THE SURGEON WAS UNLIKELY TO AUTHORIZE THE PATIENT FOR SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE MFR. REPORTS #3007566237-2013-01607 AND #3007566237-2013-01605 PERTAIN TO THIS PATIENT AND EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT CONTINUED TO HAVE OPEN CIRCUITS DUE TO THE LEADS AND EXTENSIONS BEING KINKED FROM TWISTING, AND THE LEADS AND EXTENSIONS HAD NOT PREVIOUSLY BEEN REPLACED. IT WAS NOTED THAT THE PATIENT WAS SEEN FOR A SURGERY CONSULT IN 2012 BUT THE NEUROSURGEON DID NOT WANT TO REPLACE THE LEADS BECAUSE THE PATIENT WAS NO LONGER A GOOD SURGICAL CANDIDATE DUE TO UNRELATED DISEASE STATES AND THE PATIENT WAS ¿ON A FEW ANTICOAGULANTS.¿ IT WAS NOTED THAT THE PATIENT HAD BEEN EXPERIENCING INTERMITTENT STIMULATION AND HIGH IMPEDANCES SINCE THE 2011 REPLACEMENT, BUT THERE WAS NO PLAN IN PLACE TO RESOLVE THE ISSUE. THE REPORTER STATED THAT THE PRODUCTS ¿HAD WORKED AS THEY SHOULD¿ AND THE ISSUE WAS ¿PATIENT RELATED¿ WITH CONTINUAL TWISTING OF THE WIRES. ADDITIONAL INFORMATION REGARDING THE TWISTING AND THE PATIENT¿S PREVIOUS DEVICE CAN BE FOUND IN MFR. REPORT # 3004209178-2010-02459. IT WAS UNCLEAR IF THE IMPLANTABLE NEUROSTIMULATOR AND ADAPTER WERE REPLACED AS REPORTED IN MFR. REPORT #3007566237-2013-01607, AS IT WAS INDICATED THAT THE PATIENT LAST HAD A DEVICE REPLACEMENT IN (B)(6) 2011, WHEN THE DEVICE WAS IMPLANTED, AND THE PATIENT HAD SURGERY CONSULT IN 2012. THE REPLACEMENT MAY REFER TO A PREVIOUS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120114 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention