BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 12146642 · Received July 9, 2021

    Report

    Report Number
    3004209178-2021-10629
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 9, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000420987
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCE WAS FOUND PRE AND POST OP FOR BATTERY REPLACEMENT. RIGHT LEAD ALL CONTACTS EXCEPT ACTIVE CONTACT 9 WERE OUT OF RANGE: C/10 7311 OHMS, C/8 23,457 OHMS C/9 1124 OHMS ACTIVE CONTACT 9/10 1421 OHMS. ALL COMBINATIONS WITH 11 HIGH, 9/8 23,962 OHMS, 9/10 24194 OHMS. LEFT LEAD CONTACT ?2/C 22,542 OHMS, 2/0 27,084 OHMS, 1/2 26;756 OHMS, 2/3 24,04 <(>&<)> OHMS ALL OTHERS WITHIN NORMAL LIMITS. THERE WAS NO CHANGE IN IMPEDANCE WITH THE EXCEPTION OF 9/10 WHICH IMPROVED FROM INVESTIGATE TO NORMAL LIMITS WHEN CONNECTED TO THE NEW IMPLANT.¿ PATIENT REPRESENTATIVE REPORTED PATIENT HAVING INTERMITTENT RIGHT SIDE DYSKINESIA¿STARTING TWO DAYS AFTER REPLACEMENT.¿ PRE OP AND POST OP SETTINGS WERE REVIEWED TO CONFIRM ALL SETUP AS INTENDED AND IT WAS. ON (B)(6) 2021 MPXR 852968_UPDATE (REP): PATIENT TRIED TO INCREASE WITH IN HER ACTIVE GROUP AND STEM WOULD NOT INCREASE ANDGAVE ERROR THAT OUTPUT COULD NOT BE ACHIEVED. THE PATIENT SWITCHED TO GROUP B WHICH WAS SIMILAR TO ACTIVE GROUP WITH SLIGHTLY LOWER PULSE WIDTH AND DID NOT GET AN ERROR. DYSKINESIA ON RIGHT BODY CONTINUES. ON (B)(6) 2021 MPXR 852968 (REP):THE PATIENT WAS SEEN IN CLINIC. THEY DEMONSTRATED SERVICE CODE 1703 ON PATIENT PROGRAMMER. CLINICIAN P ROGRAMMER SHOWED OOR UPON INTERROGATION. LEFT GPI NOWSHOWS CONTACT 1 >5K AND ALL COMBOS WITH CONTACT 1 >10K AT BATTERY REPLACEMENT THESE CONTACTS WERE ALL WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043012 PERCEPT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. B35200 00763000420987

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR