BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 4303983 · Received December 8, 2014

    Report

    Report Number
    3004209178-2014-22744
    Event Type
    Death
    Date Received
    December 8, 2014
    Report Date
    May 25, 2021
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NUEROSTIMULATOR (INS) FOUND THAT THE INS BATTERY WAS FOUND TO BE DEPLETED. THE DESTRUCTIVE ANALYSIS OF THE BATTERY WAS NOT NECESSARY SINCE AFTER OBTAINING THE IR AND TRACE REPORT DATA FROM THE INS, IT WAS DETERMINED THAT THE INS HAD MET ITS EXPECTED LIFE BASED ON LONGEVITY ESTIMATE FROM THE DATA. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN; PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN; PRODUCT TYPE EXTENSION PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A LOSS OF EFFICACY WHICH WAS UNRELATED TO THE STIMULATION THERAPY. THEY ARRIVED AT THE EMERGENCY ROOM DUE TO THE RETURN OF TREMOR. IT WAS AFTER A PROGRAMMING SESSION THAT HAD OCCURRED EARLIER THE DAY PRIOR TO REPORT. THEIR SYMPTOMS WERE SIMILAR TO WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF AND THEY ALSO HAD A TONGUE SENSATION OF ¿BEING PULLED BACKWARD.¿ THE TREMOR STARTED IMMEDIATELY AFTER THE PROGRAMMING SESSION WITH THEIR MANAGING PHYSICIAN. IT WAS NOTED THEY WERE ABLE TO CHANGE THE PATIENT¿S SETTINGS BACK TO THE SETTINGS THEY HAD IN 2013. THERE WAS AN IMMEDIATE IMPROVEMENT AFTER THE RATE WAS CHANGED. HOWEVER, THE PATIENT STILL HAD A TREMOR. THE PATIENT HADN¿T HAD ANY MEDICATION RECENTLY WHICH THEY THOUGHT COULD BE ANOTHER CAUSE FOR SOME TREMOR. ADDITIONAL INFORMATION REPORTED THE INS BATTERY VOLTAGE WAS AT 2.73V AND THE STIMULATION WAS ON. THE PATIENT HAD HEAD PAIN, NECK TIGHTNESS, AND LEFT SIDE TREMOR RETURN TO ¿PRE-DEVICE IMPLANT.¿ TWO WEEKS PRIOR TO REPORT, THE PATIENT HAD A RE-ADJUSTMENT PROGRAMMED FOR TIGHTNESS OF HIS TONGUE AND LEFT SIDE TREMOR AND THE SETTINGS WERE REPROGRAMMED BACK TO 2013. THE LEFT SIDE VOLTAGE WAS CHANGED FROM 3.5V TO 3.4V AND THE RIGHT SIDE FROM 4.3V TO 4.1V. THE PATIENT FELT A LITTLE IMPROVEMENT WITH HIS TONGUE TIGHTNESS. THERE WAS NO FALLS OR TRAUMA AND NO X-RAY WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NOT A 50% OR GREATER SYMPTOM REDUCTION AND THE CAUSE OF THE EVENT WAS NOT DETERMINED. WHILE REPROGRAMMING WAS DONE, THE PATIENT HAD SEVERE PARKINSON¿S SYMPTOMS OF TREMOR, BRADYKINESIA, AND THEY COULDN¿T TALK ON 2014 (B)(6). THE LOSS OF THERAPEUTIC EFFECT AND THE LOSS OF STIMULATION WERE SUDDEN. THE PATIENT WAS ADMITTED TO THE MEDICAL CENTER ON 2014 (B)(6) AND WAS DISCHARGED ON 2014 (B)(6) . THE PATIENT DIED 7 DAYS AFTER BEING DISCHARGED AND IT WAS UNKNOWN IF THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791112 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Death| H