BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7506801 · Received May 11, 2018

    Report

    Report Number
    3004209178-2018-10668
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Date of Event
    March 1, 2018
    Report Date
    June 8, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4): EVENT DATE WAS UPDATED AS AN EARLIER EVENT DATE WAS PROVIDED BY THE HEALTHCARE PROVIDER. EVENT DATE IS AN APPROXIMATE. UPDATED FROM PRODUCT PROBLEM TO PRODUCT PROBLEM AND ADVERSE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT HAD ELEVATED IMPEDANCES WITH AN UNKNOWN CAUSE. ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS INCLUDED THE PATIENT HAVING A RECENT INS REPLACEMENT SURGERY. NOW IMPEDANCES ARE ELEVATED. DIAGNOSTICS/TROUBLESHOOTING INVOLVED MULTIPLE IMPEDANCE READINGS. INTERVENTIONS/ACTIONS INCLUDED PROGRAMMING AROUND AFFECTED CONTACTS. THE ISSUE IS NOT RESOLVED AT THIS TIME. NO SURGICAL INTERVENTION OCCURRED AND NONE IS PLANNED. PROCEDURE/DBS PROGRAMMING: LEFT ELECTRODE: LEAD C+5- FREQ 80 VOLT 1.2 PW 90 RIGHT ELECTRODE: LEAD C+1- VOLT 2.4 PW 140 THERAPY IMPEDANCE: L- 3828 OHMS, 1.60MA R- HIGH OHMS, 1.55MA IMPEDANCES (REF. RANGE: UNIPOLAR: 250-2,000; BIPOLAR: 250-4,000): AT 3.0V LEFT STN: C4 3680, C5 2604, C6 701, C7 650, 4538, 3924, 4404, 2420, 3106, 1022. RIGHT STN: C0 849, C1 7918, C2 7839, C3 763, 8228, 8228, 1281, 15037, 8164, 8185, IMPEDANCES AND SETTINGS IN 10/'17 LEFT ELECTRODE: LEAD C+5- FREQ 80 VOLT 1.6 PW 90 RIGHT ELECTRODE: LEAD C+1- VOLT 2.4 PW 140 THERAPY IMPEDANCE: L- 869 OHMS, 1.86MA R- 2007 OHMS, 1.24MA IMPEDANCES (REF. RANGE: UNIPOLAR: 250-2,000; BIPOLAR: 250-4,000): LEFT STN: C4 3164, C5 883, C6 711, C7 454, 2635, 3192, 3221, 982, 1033, 767. RIGHT STN: C8 1366, C9 1845, C10 4408, C11 1266, 2498, 5379, 837, 6009, 2470, 4953.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THIS EVENT FROM A HEALTHCARE PROVIDER AND MANUFACTURING REPRESENTATIVE. THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT HAD A SEVERE DECLINE IN ABILITIES AROUND (B)(6) 2018 SHORTLY AFTER REPLACEMENT. THE HCP REPORTED THAT THE MEDICATION THAT THE PATIENT IS TAKING IS ONLY LASTING FOR A COUPLE HOURS. THE HCP REITERATED THE ELEVATED IMPEDANCES, SAYING NOTHING WAS OVER >40,000. HCP REPORTED FREQUENT FALLS BY THE PATIENT BUT THERE IS NO KNOWN ACTIVITY OR EVENT THAT PROMPTED THE ISSUE. HCP STATED THAT CHEST X-RAYS SHOWED EVERYTHING WAS INTACT. HCP STATED: "THEY HAVE TAKEN IMPEDANCES THAT ARE ELEVATED RELATED TO NORMAL BUT NOTHING IS OPEN." IMPEDANCES WERE TESTED AND RESULTS WERE: C1 7918 PROGRAMMED. ADDITIONAL IMPEDANCES PROVIDED INCLUDED: C0 1387 C2 7505 C3 854 01 8843 13 8000S 23 7736 IMPEDANCES WERE ALSO TAKEN WITH HEAD TURNED RIGHT AND THERE WAS NO CHANGE. IT WAS REVIEWED TO RUN GROUP IMPEDANCE MEASUREMENTS AND RESULTS WERE HIGH. CURRENT PROGRAMMED SETTINGS: 2.4V 80R 140PW. THE FOLLOWING TROUBLESHOOTING WAS REVIEWED: RE-RUN ELECTRODE IMPEDANCE AT HIGHER AMPLITUDE (IF MEDICALLY APPROPRIATE). TAKE IMPEDANCES IN VARIOUS ROM OR POSITIONS. DISCUSS X-RAY/FLUOROSCOPY. HCP WAS ABLE TO REPROGRAM RATE OF 80 TO 60 AND C1 TO C0 AND C5 TO C4. THEY ALSO DECREASED AMPLITUDES WITH PATIENT REPORTING CONTROL OF PARKINSON'S SYMPTOMS AND DYSKINESIA. TROUBLESHOOTING WAS REPORTED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE INDICATING THAT THE CAUSE OF THE ELEVATED IMPEDANCES WAS NOT DETERMINED, THE EVENT IS STILL NOT RESOLVED AND THEY REPORT THAT THE THERAPY IS MORE DIFFICULT TO MANAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351426 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR