BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8200137 · Received December 27, 2018

    Report

    Report Number
    3004209178-2018-28438
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    December 22, 2018
    Report Date
    February 14, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP INDICATING THERE WAS ELEVATED IMPEDANCE ON CONTACT 3 AND C. PRIOR TO THE MRI SCAN, THE IMPEDANCE WAS 2,500 AT C3. THE REP ATTEMPTED TO GET THEM TO DECREASE MY INCREASING AMPLITUDE BUT IT DIDN'T WORK. INTRA OP TESTING THE LEAD AND SHOWED CONTACT 3 AT 6900. PRIOR TO SURGERY C3 WERE AT 2,700. IT WAS NOTED THAT THE PATIENT WAS GETTING GOOD THERAPY. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL, MOVEMENT DISORDERS. IT WAS REPORTED THAT THE HCP WAS USING THE 8840 TO CHECK IMPEDANCES PRIOR TO AN MRI FOR THE PATIENT. VALUES WERE TAKEN AT 3V: CO 1265 C1 1101 C2 1094 C3 2487 01 1279 12 1649 03 3150 12 1067 13 2465 23 1792 THE CALLER WAS CONCERNED THAT C3 FALLS OUTSIDE OF THEIR GUIDELINES FOR MRI. TECHNICAL SERVICES REVIEWED THAT WHILE THAT VALUE ITSELF WASN¿T TOO CONCERNING, IT DIDN¿T ALIGN WITH THE REST OF THE VALUES. THE CALLER ADDED THAT THE PATIENT MENTIONED THAT THIS SIDE IS ¿NOT OK.¿ THE CALLER WOULD NOT PERFORM THE MRI AND SENT THE PATIENT BACK TO THEIR MANAGING HCP TO DISCUSS FURTHER, AS THEY DID NOT WANT TO RISK AN MRI IF THERE WAS A PROBLEM WITH THE SYSTEM. TECHNICAL SERVICES REVIEWED THEY WOULD WANT TO CONSIDER PAST IMPEDANCE VALUES AS WELL AS IF THE PATIENT HAD ANY FALLS OR TRAUMA OR CHANGES IN THERAPY. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039113 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR