BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3309214 · Received August 26, 2013

    Report

    Report Number
    3004209178-2013-15216
    Event Type
    Malfunction
    Date Received
    August 26, 2013
    Date of Event
    July 28, 2013
    Report Date
    July 30, 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 Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40, LOT# V191279, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40, LOT# V191279, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED IN (B)(6) 2013 AND WAS CURRENTLY HAVING ISSUES WITH PATIENT PROGRAMMER SETTINGS. THE REPORTER STATED THEY WENT TO SEE THEIR HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2013. IT WAS NOTED THE HCP TRIED TO USE THE PATIENT¿S PROGRAMMER AND THE PROGRAMMER WOULD NOT WORK. IT WAS FURTHER NOTED THE HCP TRIED TO SET THE NUMBERS AND THE PROGRAMMER REVERSED THE NUMBERS. IT WAS NOTED THE HCP USED THEIR CLINICIAN PROGRAMMER AND SET IT. THE REPORTER STATED THE HCP AND MANUFACTURING REPRESENTATIVE THINKS THERE IS A ¿GLITCH IN IT OR SOMETHING.¿ IT WAS NOTED THE MANUFACTURING REPRESENTATIVE RECOMMENDED THE PATIENT REQUEST A REPLACEMENT FOR THE PROGRAMMER. ANALYSIS OF THE PATIENT PROGRAMMER FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DAYS AGO, THE PATIENT WAS FINE. TWO DAYS AGO, THE PATIENT STARTED HAVING A RETURN OF SYMPTOMS OF DYSKINESIA AND ¿FREEZING TYPE OF SITUATION.¿ THE PATIENT WAS RIDING HER STATIONARY BIKE THAT HAD MAGNETS IN THE FOOT PEDALS, AND WAS NOT SURE IF THIS WAS WHY SHE WAS NOT FEELING WELL THAT DAY. YESTERDAY, THE PATIENT SAW HER DOCTOR AND HAD HER SETTINGS CHANGED. TODAY, THE PATIENT WAS FEELING FINE WITH NO SYMPTOMS. IT WAS ALSO REPORTED THAT THERE WAS SOMETHING WRONG WITH THE PATIENT¿S PROGRAMMER BECAUSE, THE SETTINGS HAD BEEN SWITCHED. IT WAS NOTED THAT THE PATIENT HAD 1.9V ON THE LEFT AND 3.7V ON THE RIGHT AND THEN THE SETTINGS GOT SWITCHED ON THE PROGRAMMER. THE PATIENT WAS INSTRUCTED TO CONTACT THE MANUFACTURE BECAUSE, THE PROGRAMMER WAS NOT WORKING. THE PROGRAMMER WAS CHECKED AND EVERYTHING SEEMED FINE. IT WAS UNCLEAR WHAT THE PROBLEM WAS WITH THE PROGRAMMER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S DOCTOR THOUGHT THERE WAS SOME KIND OF GLITCH WITH PROGRAMMER, BECAUSE, THE NUMBERS WERE REVERSED WHEN HE TRIED TO REPROGRAM. THERE WAS NO INDICATION OF PRODUCT DEFECT AND NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417650 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR