BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6931916 · Received October 9, 2017

    Report

    Report Number
    3004209178-2017-21435
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    October 4, 2017
    Report Date
    December 7, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: FULL PHONE NUMBER (WITH EXTENSION) IS (B)(6). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3387-40 LOT# V002359 IMPLANTED: (B)(6)2006 PRODUCT TYPE LEAD PRODUCT ID 748251 UNKNOWN IMPLANTED: (B)(6)2006 PRODUCT TYPE EXTENSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR MOVEMENT DISORS. IT WAS REPORTED THAT THE INS WAS AT EOS AND THE VOLTAGE WAS 2.80V. THE DEVICE HADERD BEEN IMPLANTED FOR 6 MONTHS AND THERE WERE SHORT CIRCUITS WITH IMPEDANCES OF 89 OHMS ON CONTACTS 1 AND 3, WHICH WERE ACTIVE ELECTRODES IN THE PATIENT¿S PROGRAMMED SETTINGS. NO MEDICAL SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP STATED THAT THE CAUSE OF THE FRACTURE WAS DUE TO THE AGE OF THE LEAD AS IT WAS IMPLANTED IN 2013. FURTHERMORE, AS THE DEVICE WAS IMPLANTED SO LONG AGO THE EXTENSION IS "MORE MOVE-ABLE" TODAY. NO REVISION WAS PERFORMED AS THE NEUROSURGEON DID NOT WANT TO TOUCH THE DEVICE AND RISK HAVING TO REPLACE THE WHOLE SYSTEM, WITH THE SURGEON BELIEVING THE LEAD TO BE THE ISSUE AND NOT THE EXTENSION. THE HCP DECIDED TO PROGRAM AROUND THE ISSUE AS A RESULT. THE PATIENT'S WEIGHT AND RELATED SERIAL NUMBERS COULD NOT BE OBTAINED. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP INDICATING THE PATIENT HAD A NEW INS IMPLANTED AND THEY WERE PROGRAMMING AROUND THE SHORT CIRCUIT, AS THE CLINICIAN FEARED A FRACTURED IN THE LEAD. THE LEAD/EXTENSION CONNECTION WAS NOT AS HIGH AS IT WAS ORIGINALLY PLACED, AND THE HCP SUSPECTED THE CONNECTION MAY HAVE SLID DOWN. THE HCP WAS CONCERNED IF THEY TRIED REPLACING THE EXTENSION THEY WOULD DAMAGE THE LEAD FURTHER AND WERE TRYING TO AVOID BRAIN SURGERY AS LONG AS THEY COULD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710099 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR