BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2568757 · Received May 10, 2012

    Report

    Report Number
    3004209178-2012-03171
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Date of Event
    April 11, 2012
    Report Date
    April 11, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD MODEL 3389S-40, LOT# V952317, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012; LEAD MODEL 3389S-40, LOT# V952317, IMPLANTED: (B)(6) 2012, EXPLANTED: NA; EXTENSION MODEL 37085-60, IMPLANTED: (B)(6) 2012, EXPLANTED: NA. ANALYSIS OF THE LEAD MODEL 3389S-40 LOT V952317 FOUND NO SIGNIFICANT ANOMALIES. SUSPECTED BODY FLUIDS WERE OBSERVED IN THE LEAD WITH NO IMPACT ON PERFORMANCE. NORMAL IMPEDANCES WERE OBSERVED WHEN TESTED IN A SALINE SOLUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TESTING IMPEDANCES DURING IMPLANT HIGHER THAN NORMAL IMPEDANCES WERE SEEN ON ALL COMBINATIONS INVOLVING ELECTRODE ONE. DURING THE FIRST TEST, ALL ELECTRODE COMBINATIONS WERE AROUND 2,000-3 ,000 OHMS, WHILE THE COMBINATIONS INCLUDING ELECTRODE ONE WERE ALL OVER 10,000 OHMS. TRYING DIFFERENT VOLTAGES, DIFFERENT TESTING CABLES AND A DIFFERENT ENS YIELDED NO CHANGE IN RESULTS. THE LEAD WAS REPLACED AND THE SAME ISSUE ON CONTACT ONE WAS SEEN AGAIN. THE IMPEDANCES DECREASED DOWN TO 6,000-7,000 OHMS AND THE PHYSICIAN DECIDED TO CLOSE THE PATIENT, SINCE IT HAD ALREADY TAKEN SO MUCH TIME REPLACING THE FIRST LEAD. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS A 'BAD LEAD.' IMPEDANCES WERE NORMAL AFTER CONNECTED TO THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). A LONG-TERM FOLLOW UP TEST SHOWED NORMAL VALUES AS WELL. THE PATIENT DID NOT NEED TO BE HOSPITALIZED. NO PATIENT INJURY WAS REPORTED. LONGTERM THERAPY WAS REPORTED TO BE NORMAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR