BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2831349 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10230
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 15, 2012
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3389-40, LOT# J0527920V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 3389-40, LOT# J0527920V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A LOT OF PAIN IN HER NECK AND COULD NOT TURN HER HEAD. THE REPORTER STATED THAT PAIN WOKE HER UP AT NIGHT. IT WAS STATED THAT THE PAIN STARTED THE FIRST WEEK OF (B)(6) 2012. THE PAIN WAS DESCRIBED AS "BURNING IN THE BACK OF THE NECK." IT WAS NOTED THAT THE PATIENT ATTEMPTED TO TURN UP THE RIGHT SIDE STIMULATION, BUT HER LEFT HAND TINGLED AND SHOOK. IT WAS ALSO STATED THAT THE PATIENT ATTEMPTED TO ADJUST THE LEFT SIDE STIMULATION IN BOTH DIRECTIONS, BUT WAS UNABLE DUE TO PROGRAMMING RESTRICTIONS. IT WAS NOTED THAT PATIENT ALSO TRIED TO ADJUST THE RIGHT SIDE STIMULATION, BUT THE PATIENT PROGRAMMER FROZE SEVERAL TIMES, THEN WENT "BLANK" AND WOULD NOT TURN ON. THE REPORTER ALSO STATED SHE HAD CERVICAL DYSTONIA AND THAT HER OLD DEVICES WORKED FINE BEFORE THEIR REPLACEMENT IN 2006. IT WAS REPORTED TWO WEEKS LATER THAT THE PATIENT WAS EXPERIENCING TIGHTENING ON THE RIGHT SIDE OF THE NECK, ALONG WITH PAIN. IT WAS STATED THAT THE DEEP BRAIN STIMULATORS (DBS) HELPED TO KEEP THE PATIENT'S HEAD STRAIGHT. IT WAS ALSO STATED THAT THE PATIENT COULD NOT TURN HER HEAD TO THE RIGHT. IT WAS NOTED THAT THE PATIENT HAD SLURRED SPEECH IN COMPARISON TO TWO WEEKS PRIOR. THE REPORTER STATED SHE WORKED WITH HER HEALTH CARE PROVIDER (HCP) TO DECREASE THE VOLTAGE AND HER VOICE WAS BETTER. THE REPORTER ALSO STATED THAT SHE WAS STILL NOT 100% AND WOULD MAKE A FOLLOW UP APPOINTMENT WITH HER HCP TO BE REPROGRAMMED. THE PATIENT WAS ALSO PRESCRIBED MEDICATION FOR PAIN AS WELL. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE IN TIME FOR THIS REPORT. ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT. PLEASE REFERENCE MFR. REPORT # 3004209178-2012-10228, AS THE PATIENT HAS BILATERAL SYSTEMS AND IT WAS UNCLEAR WHICH SYSTEM HAD THE ALLEGATION OF MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1