BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4321158 · Received December 11, 2014

    Report

    Report Number
    3004209178-2014-23732
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Date of Event
    November 20, 2014
    Report Date
    December 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389S-40, LOT# VA00B3P, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# V952317, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37601, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (S/N (B)(4)) FOUND NO SIGNIFICANT ANOMALY; THE INS BATTERY HAD NORMAL END OF LIFE AND THE TELEMETRY AND OUTPUT WERE OKAY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE CAUSE OF THE IMPEDANCE ISSUE WAS MOISTURE WITH INSERTION, AS ALL RESOLVED WHEN DRIED AND RE-INSERTED INTRA-OPERATIVELY. THE STATUS OF THE PATIENT WAS REPORTED AS RECOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS BEING CHANGED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI). PRIOR TO SURGERY, IMPEDANCES WERE MEASURED TO BE GREATER THAN 40,000 OHMS ON CASE-10 AND CASE-11. DURING THE REPLACEMENT SURGERY THE HEALTHCARE PROFESSIONAL (HCP) HAD DIFFICULTY REMOVING THE RIGHT EXTENSION FROM THE INS. THE NEW INS WAS IMPLANTED AND INTRAOPERATIVE IMPEDANCE TESTING SHOWED IMPEDANCES GREATER THAN 40,000 OHMS ON CASE-NINE AND 10-11. THE HCP REMOVED THE EXTENSION FROM THE INS, WIPED THE CONTACTS, AND RE-INSERTED THE EXTENSIONS. ALL IMPEDANCES WERE THEN MEASURED TO BE NORMAL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT AND THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. INFORMATION UNRELATED TO THIS EVENT WAS INCLUDED IN A SEPARATE PE; SEE PE (B)(6) FOR HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803861 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR