BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4221131 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20851
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 13, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT# VA0136M, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# VA00CFP, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S SPOUSE HAD BEEN NOTICING SOME SYMPTOMS OVER THE PAST PERIOD. A PROBLEM WITH THE PATIENT PROGRAMMER WAS REPORTED AND THE PATIENT¿S SPOUSE SAW A CHANGE THE PATIENT PROGRAMMER BATTERY SCREEN. THE PROGRAMMER BATTERIES WERE REPLACED AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHECKED. THE INS WAS ON PROGRAM A AT 2.60 AND 1.70. THE PATIENT STATED THAT WHEN THE PROGRAMMER BATTERIES WERE WEAK THE PROGRAMMER AND INS COULD NOT COMMUNICATE. THREE MONTHS PRIOR TO THIS REPORT THE PATIENT MET WITH THEIR HEALTHCARE PROFESSIONAL AND THE INS STILL HAS TWO MORE YEARS, BUT THERAPY HAD NOT BEEN AS EFFECTIVE. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT FOLLOWING A FALL. SHORTLY AFTER IMPLANT THE PATIENT NEEDED TO GO TO THERAPY TO GAIN USE OF THEIR ARM AND SHOULDER. DURING THERAPY THE RIGHT INS HAD MOVED SLIGHTLY IN THE CHEST, BUT AFTER A YEAR OF THERAPY THE INS HAD MOVED A SUBSTANTIAL DISTANCE. THE INS WAS NOW TOUCHING A BONE THAT IT HAD NOT BEFORE. THE PATIENT DID HAVE MORE PROBLEMS WITH THEIR LEFT SIDE IN GENERAL. THE PATIENT¿S SPOUSE WONDERED IF THE LEFT SIDE HAD LOWER STIMULATION THAN IT SHOULD BE. AFTER THE PATIENT TOOK THEIR MEDS ¿IT SHOULD HAVE A LITTLE SURGE, NOT FROM THE TRANSMITTER, JUST THE BODY IN GENERAL.¿ THE PATIENT HAD NOT GOTTEN ¿A BOOST.¿ AT THE TIME OF THIS REPORT THE PATIENT HAD JUST TAKEN THEIR MEDICATIONS AS THE PREVIOUS DOSE WAS WEARING OFF. THE PATIENT HAD LESS ENERGY AND THEY WERE WEAKER. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702427 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR