BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6080941 · Received November 7, 2016

    Report

    Report Number
    3004209178-2016-23300
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    April 7, 2014
    Report Date
    January 19, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    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

    PRODUCT CODE WAS INCORRECTLY ENTERED. THIS VALUE HAS BEEN UPDATED TO MRU INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM, OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387-40 ,LOT# J0428156V, PRODUCT TYPE: LEAD . PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. THE PMA / 510(K) NUMBER WAS INCORRECTLY ENTERED. THIS VALUE HAS BEEN UPDATED TO (B)(4). UPON FURTHER REVIEW IT WAS DETERMINED THAT (B)(4) SHOULD BE REMOVED AS DEVICE CODE (B)(4) IS MORE APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL # (B)(4)) REVEALED NO SIGNIFICANT ANOMALIES, BATTERY REACHED NORMAL END OF LIFE AND TELEMETRY AND OUTPUT WERE OKAY. CONCLUSION CODE APPLIES TO THE IMPLANTABLE NEUROSTIMULATOR.

    Additional Manufacturer Narrative · 1

    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

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT WAS HAVING INEFFECTIVE THERAPY DUE TO BATTERY DEPLETION SINCE (B)(6) 2016. IT WAS NOTED THAT THE PATIENT HAD BEEN HAVING HIGH IMPEDANCE ISSUES SINCE (B)(6) 2016 AND SUFFERED A FALL IN 2014. ELECTRODE IMPEDANCE TESTED AT 1.5V: C0: 10068 OHMS C1: 7511 OHMS C2: 5365 OHMS C3: 8182 OHMS 01: 5979 OHMS 02: 7668 OHMS 03: 9824 OHMS 12: 3912 OHMS 13: 5851 OHMS 23: 3637 OHMS

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED. IT WAS ALSO STATED THATTHE SHORT WAS DUE THE FALL AFFECTING THE EXTENSIONS / WIRES SO THE PATIENT WAS REPROGRAMMED AROUND THE IMPEDANCE ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE NEUROLOGIST FEELS THAT THEY WERE ABLE TO PROGRAM AROUND SOME OF THE ISSUES, AND PATIENT IS STILL RECEIVING THERAPY. IT WAS REPORTED THAT AN IMPEDANCE CHECK WAS RUN AT 3.0V. IT WAS REPORTED THAT SEVERAL OF THE PRIOR "OUT OF RANGE" ELECTRODES HAVE BEEN RESOLVED. IMPEDANCE TESTED AT 3.0V: C0: 5585 OHMS C3: 2403 OHMS 01: 4603 OHMS 02: 4603 OHMS 03: 4845 OHMS 12: 37 OHMS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733272 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR