BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2990337 · Received March 5, 2013

    Report

    Report Number
    3007566237-2013-00681
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED CONFIRMED AN ABNORMAL FLUCTUATION OF THE IMPEDANCES OF THE INS SYSTEM 2 WEEKS POST-SURGERY AND THAT THE IMPEDANCES MEASURED AT THE CLINIC ON (B)(6) 2013 WERE 'UNUSABLE.' THE PATIENT WAS TREATED BY ADJUSTING TO THE 'USABLE' ELECTRODES ON THE INS SYSTEM. THE PATIENT WAS BEING FOLLOWED UP AND THE CAUSE OF THE IMPEDANCE ISSUE HAD YET TO BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEAD WAS NOT CONFIRMED TO BE DAMAGED. THE PATIENT'S PARAMETERS HAD BEEN CHANGED TO 0-, 2+. THE POSSIBLE CONNECTION FAILURE PREVIOUSLY REPORTED HAD NOT BEEN CONFIRMED AND THE CAUSE OF THE PARESTHESIA IN THE PATIENT'S NECK WAS UNDETERMINED. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT ON (B)(6) 2013 THE PATIENT HAD A MEETING WITH THE HEALTHCARE PROFESSIONAL (HCP) AND MANUFACTURING REPRESENTATIVE. THE CAUSE OF INCREASED ELECTRODE IMPEDANCE WAS EXPLAINED USING THE ANALYSIS REPORT; THE REMINDER FOR THE PATIENT, AVAILABLE DATE ON THE LEAD DAMAGE, AND CONSIDERATIONS TO ABNORMAL VALUES DEPENDING ON DIVERSE ELECTRODES. IT WAS NOTED THAT THE CHANGE OF THE POSITION OF ABNORMAL IMPEDANCE VALUES ON ELECTRODES CAUSED THE DOCTOR AND PATIENT GREAT UNEASINESS. IT WAS NOTED THAT A FAILURE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS HIGHLY UNLIKELY. IT WAS FURTHER NOTED THAT THE CAUSE WAS NOT CLEAR AND THE DOCTOR WAS UNSURE WHETHER TO RE-OPERATE OR NOT. ON (B)(6) 2013 THERE WAS ANOTHER MEETING WITH THE PATIENT, HCP AND MANUFACTURING REPRESENTATIVE. THE HCP CONCLUDED THAT THERE WAS NO PROBLEM IN THE MEASUREMENT PROCESS. IT WAS NOTED THAT THE FAILURE IN LEAD OR EXTENSION OR BAD CONNECTION SOMEWHERE IN THE INS HAD A HIGH PROBABILITY. IT WAS DECIDED TO FOLLOW UP AT A 2-C+ 1552 OHMS SETTING INSTEAD OF REOPERATION WHICH WAS CAPABLE OF INFESTATION. ON (B)(6) 2013 THERE WAS ANOTHER MEETING WITH THE PATIENT, HCP, AND MANUFACTURING REPRESENTATIVE. THE PATIENT HAD CONTINUOUS DISCOMFORT IN THE RIGHT SIDE OF THE NECK AT THE INS ON STATUS. IT WAS NOTED THAT THE DISCOMFORT DISAPPEARED WHEN THE INS WAS SWITCHED OFF. THE DOCTOR ADJUSTED THE POLAR TO 1-3+, 2.0V, 2326OHMS AND DISCOMFORT FEELING DECREASED BUT SOME REMAINED. 0-2+, 2.0V 1942 OHMS WERE SET AND DISCOMFORT FEELING DECREASED FURTHERMORE. IT WAS FURTHER NOTED THAT AS THE SYMPTOMS GOT WORSE AT MONOPOLAR, PRIORITY WAS GIVEN TO BIPOLAR SETTINGS. FOLLOW-UP AT THE ABOVE SETTINGS BECAUSE THE TREATMENT EFFECT PERSISTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED ON (B)(6) 2013 STATED THAT THE PATIENT COMPLAINED ABOUT A CONTINUOUS TINGLING FEELING IN THE RIGHT SIDE OF THE NECK. PER THE PATIENT'S PHYSICIAN THE CAUSE OF THE EVENT WAS UNKNOWN, THEREFORE, THE EXPLANATIONS AND DECISIONS REGARDING THE COURSE OF TREATMENT HAVE NOT BEEN GOING SMOOTHLY. THE PHYSICIAN WAS REQUESTING AN INVESTIGATION OF THE CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED ON (B)(6) 2013. THERE WERE NO IMPEDANCE ANOMALIES FOUND AFTER THE OPERATION. WHEN THE PATIENT CAME BACK FOR A FOLLOW UP APPOINTMENT ON (B)(6) 2013 AN IMPEDANCE ABNORMALITY WAS FOUND. IT WAS STATED THAT THE DOCTOR "ADJUSTED THE SETTINGS OF OTHER NORMAL ELECTRODES", AND DECIDED TO FOLLOW UP WITH THE PATIENT OVER TIME. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93946 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37602

    Patients

    Seq Age Sex Outcome Treatment
    1