BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6846097 · Received September 6, 2017

    Report

    Report Number
    3004209178-2017-18831
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 8, 2016
    Report Date
    September 6, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: EXTENSION. 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.

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE PATIENT BROKE THEIR BACK IN AN ACCIDENT AND FALL. AFTER THE ACCIDENT, THE PATIENT GOT A STRANGE FEELING AND TINGLING IN THEIR ARM WHEN THEY MOVED THEIR NECK IN DIFFERENT POSITIONS, ESPECIALLY WHEN LEANING HIS HEAD BACK. THE HCP CHECKED IMPEDANCES AND HIGH IMPEDANCES WERE MEASURED WHEN THE PATIENT MOVED THEIR HEAD FORWARD AND BACKWARDS. IMPEDANCES WERE MEASURED WHEN THE PATIENT LEANED THEIR HEAD FORWARD AND BACKWARDS AND WHEN IT WAS STRAIGHT. IMPEDANCES WERE MEASURED TO BE NORMAL WHEN THE PATIENT'S NECK WAS STRAIGHT. THE INS WAS PROGRAMMED TO 1.4V, 60 USEC, AND 140 HZ. X-RAYS WERE DONE AND THE SYSTEM LOOKED COMPLETE WITH THE LEAD AND EXTENSION OKAY. AS OF (B)(6) 2017, THE INS WAS PROGRAMMED TO 1.4V, 60 USEC, AND 140 HZ. THE HCP PLANNED ON CHECKING THE CONNECTIONS BETWEEN THE INS AND EXTENSION AND BETWEEN THE EXTENSION AND LEAD. DEPENDING ON WHAT THE HCP FINDS, COMPONENTS MAY BE REPLACED. SINCE THE ACCIDENT, THE PATIENT HAD THE INS TURNED OFF BECAUSE OF THE CURRENT IN THEIR ARM. A TROUBLESHOOTING REVISION WAS DONE. DURING THE REVISION, IMPEDANCES OF THE LEAD WERE MEASURED TO BE NORMAL. WHEN THE EXTENSION AND LEAD IMPEDANCES WERE TESTED, HIGH IMPEDANCES WERE MEASURED ON ELECTRODE PAIR C-0. THERAPY IMPEDANCES WERE ALSO MEASURED TO BE HIGH. THE INS HAD BEEN PROGRAMMED TO C+, 0- AT 0.6 V, 60 USEC AND 150 HZ. THE HCP DECIDED TO REPLACE THE BROKEN EXTENSION AND THE INS BECAUSE OF LOW CURRENT. AFTER REPLACING THE EXTENSION AND INS, HIGH IMPEDANCES WERE MEASURED ON ELECTRODE PAIRS C-0, 0-1, 0-2, AND 0-3. THE HCP DECIDED TO LEAVE THE INS AND EXTENSION IMPLANTED SO THE TURNED STIMULATION WAS OFF AND PROGRAMMED THE INS TO 0.0 V. THE HCP WAS GOING TO START THE IMPLANTED SYSTEM ON (B)(6) 2017 AND TRY TO FIND A GOOD PROGRAM FOR THE PATIENT USING ELECTRODE ONE. THE PATIENT WAS GETTING GOOD THERAPY AND THE ISSUE WAS RESOLVED. NO FURTHER PATIENT COMPLICATIONS WERE ANTICIPATED/REPORTED. THE PATIENT'S INDICATION FOR USE IS ESSENTIAL TREMOR. REFER TO MANUFACTURER REPORT #3004209178-2017-06828.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626772 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1