BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2900422 · Received January 7, 2013

    Report

    Report Number
    3004209178-2013-00271
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 14, 2012
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, SERIAL# (B)(4), TYPE PROGRAMMER, PATIENT PRODUCT ID 3 7085-60, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V975686, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT EVERYTHING ON THE X-RAYS LOOKED GOOD. IT WAS REPORTED THAT SINCE THE PATIENT'S OFFICE VISIT ON (B)(6), THE SETTINGS HAD BEEN GOOD FOR THE PATIENT AND THE PATIENT WAS DOING WELL AND HAPPY WITH THE SETTINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THE THERAPY WAS NOT HELPING TO THE EXTENT THAT IT HELPED INITIALLY AFTER IMPLANT. IT WAS NOTED THE PATIENT WAS UNHAPPY WITH THERAPY OUTCOME AND WENT IN FOR REPROGRAMMING. IT WAS NOTED AT IMPLANT THE PATIENT HAD SPEECH SIDE EFFECTS AT 4.0 VOLTS, BUT PATIENT DID NOT HAVE SIDE EFFECTS WHEN THEY TITRATED UP TO 7.0 VOLTS THE DAY OF REPORT. IT WAS NOTED THE SAME ELECTRODE CONFIGURATION WAS USED. THERE WAS NO KNOWN INCIDENT OR ACCIDENT AND NO FALLS OR TRAUMAS. PATIENT WAS REPROGRAMMED AND SYMPTOMS SEEMED IMPROVED WITH THE NEW PROGRAMMING. IT WAS ALSO NOTED THERE WERE IMPEDANCES GREATER THAN 4,000 OHMS. WHEN IMPEDANCES WERE TAKEN AT 3.0 VOLTS ALL ELECTRODES WERE WITHIN RANGE. THE HEALTH CARE PROFESSIONAL (HCP) DID NOT HAVE HISTORICAL IMPEDANCES. HCP ALSO NOTED THE SIGNAL SEEMED LIKE "IT WAS NOT GOING ALL THE WAY THROUGH AND THE PATIENT WAS REQUIRING HIGHER VOLTAGE." IT WAS NOTED THE PATIENT HAD NOT HAD ANY CHANGES IN ORAL MEDICATION AND THAT THE PATIENT WAS CURRENTLY NOT TAKING ANY ORAL MEDICATION. HCP DID NOT BELIEVE DISEASE PROGRESSION WAS A FACTOR IN THE PATIENT'S SYMPTOMS. FOLLOW UP WITH THE HCP REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. THERE WERE ABNORMAL IMPEDANCES NOTED FOR C1, 2830 AND FOR 01, 4031. IT WAS UNKNOWN IF THE ISSUE WAS DUE TO THE IMPLANTABLE NEUROSTIMULATOR (INS) OR LEAD/EXTENSION. X-RAYS WERE TAKEN BUT RESULTS WERE NOT REPORTED. REPROGRAMMING WAS DONE AND THE PATIENT HAD ADEQUATE TREMOR CONTROL AND NO SIDE EFFECTS. SIGNS AND SYMPTOMS RELATED TO THE EVENT INCLUDED POOR TREMOR CONTROL. THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7583 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1