BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3142194 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08515
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 4, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3389-40, LOT# J0357358V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER INDICATED THAT "CLEARLY SOMETHING WAS WRONG" DUE TO THE FACT THAT PATIENT WAS GETTING SYMPTOM OF SHOCKING. IT WAS ALSO REPORTED PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS ATTRIBUTED TO THE EXTENSION. IT WAS ALSO NOTED WHEN THE PATIENT WAS REPROGRAMMED ON MAY 4, THE VOLTAGE WAS CHANGED FROM 1.9 VOLTS (V) TO 0.7 V.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION THAT BEGAN ON HIS LEFT SCALP AND RAN DOWN HIS LEFT ARM AND LEG. THE SYMPTOMS BEGAN AFTER THE PATIENT HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT IN (B)(6) 2013. THE PATIENT¿S INITIAL PROGRAMMING WAS ON C+, 0-, 1.9 VOLTS (V), PULSE WIDTH OF 120, AND 160 HERTZ (HZ). IMPEDANCE MEASUREMENTS SHOWED UNIPOLAR IMPEDANCES RANGING FROM 5600 OHMS TO 9200 OHMS. IT WAS NOTED THE SENSATION ¿SEEMED TO POSSIBLY BE RELATED TO TORSION MOTION BUT IT DID NOT PRODUCE THE SENSATION EVERY TIME.¿ PROGRAMMING WAS CHANGED FROM 0- TO 1- BUT THEN THE INS WAS PRESSED ON THERAPY WAS ADVERSELY IMPACTED. ADDITIONAL INFORMATION RECEIVED FOUR DAYS LATER REPORTED THE PATIENT ALSO EXPERIENCED THE SHOCKING OR JOLTING SENSATION ACROSS HIS CHEST AND ¿SOME FLASHING LIGHTS.¿ IT WAS NOTED IMPEDANCES WERE NORMAL, AROUND 800 OHMS, UNTIL THE INS WAS PRESSED ON WHICH ELICITED A SHOCK AND THEN THE IMPEDANCE SHOWED HIGHER, 5000 OHMS. THE PATIENT HAD BEEN REPROGRAMMED ON A DIFFERENT ELECTRODE CONFIGURATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244548 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1