BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5917931 · Received August 31, 2016

    Report

    Report Number
    3004209178-2016-17997
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    August 9, 2016
    Report Date
    August 31, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #EVALUATION DETERMINED THAT STANDARD INVESTIGATION IS NEEDED BECAUSE IT WAS REPORTED THAT IMPEDANCES ON 23 WERE 7, INDICATING A SHORT. IT WAS ALSO STATED THAT THE PATIENT HAS HAD LEAD ISSUES FOR A WHILE AND THAT HISTORICALLY IMPEDANCES HAVE BEEN WONKY. THE REPORTED INFORMATION IS AN ALLEGATION THAT SUGGESTS A POSSIBLE FAILURE OF A DEVICE, LABELING, OR PACKAGING TO MEET SPECIFICATIONS. AN ASSESSMENT OF THE SOURCE INFORMATION INDICATES THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE ALLEGED DEVICE FAILURE. ASSESSMENT DETERMINED THAT THERE IS NOT AN EXISTING FORMAL INVESTIGATION FOR THE ISSUE IDENTIFIED IN THIS EVENT. HOWEVER, A NEW FORMAL INVESTIGATION IS NOT POSSIBLE, BECAUSE THERE IS INADEQUATE INFORMATION TO INITIATE FORMAL INVESTIGATION ACTIVITIES; THE ROOT CAUSE OF THE LEAD ISSUES REMAINS UNKNOWN. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389S-40, LOT# V067936, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) REPORTED THE FOLLOWING IMPEDANCE MEASUREMENTS AS OF DATE NOTIFIED. C0 = 11000, C1 = 1620, C2 = 557, C3 = 553, 01 = 22000, 02 = 21000, 03 = 21000, 12 = 1550, 13 = 1564, 23 = 7. TROUBLESHOOTING WAS PERFORMED AND THE HCP IS GOING TO ATTEMPT PROGRAMMING AROUND THE LOW IMPEDANCES. IT WAS INDICATED THAT THE PATIENT HAS HAD LEAD ISSUES FOR A WHILE AS THIS IS THE (B)(4) IMPLANT WITH THE SAME LEADS, AND THAT HISTORICALLY IMPEDANCES HAVE BEEN "WONKY." THE IMPLANT WAS CONFIRMED TO BE ON AND SET AT 2.3. THERE WERE NO PATIENT SYMPTOMS ALLEGED, AND NO FALLS OR TRAUMA RELATED TO THIS EVENT. INDICATION FOR IMPLANT IS PARKINSON'S DUAL AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569009 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR