BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6280295 · Received January 26, 2017

    Report

    Report Number
    3004209178-2017-01802
    Event Type
    Injury
    Date Received
    January 26, 2017
    Date of Event
    January 13, 2017
    Report Date
    October 26, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994761057
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    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

    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 (B)(4) SERIAL# (B)(4) IMPLANTED: (B)(4) 2017 EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID (B)(4) LOT# V233444 IMPLANTED: (B)(4) 2009 EXPLANTED: (B)(4) 2017 PRODUCT TYPE LEAD PRODUCT ID (B)(4) SERIAL# (B)(4) IMPLANTED: (B)(4) 2017: PRODUCT TYPE EXTENSION PRODUCT ID (B)(4) LOT# VA1J9MZ IMPLANTED: (B)(4) 2017: PRODUCT TYPE LEAD.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 HEALTHCARE PROFESSIONAL VIA A MANUFACTURING REPRESENTATIVE ABOUT A PATIENT WITH AN IMPLANTABLE NEURO STIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INTERMITTENT SHOCKING SENSATIONS ON THE CONTRALATERAL (RIGHT) SIDE SINCE THEIR LAST PROGRAMMING SESSION. THE PATIENT IS REPORTED TO HAVE HAD A FALL, ALTHOUGH IT WAS NOT ON THE SYSTEM. IMPEDANCE MEASUREMENTS WERE TAKEN AND A COUPLE OF COMBINATIONS WERE REPORTED TO BE HIGH BUT NOT INDICATIVE OF AN OPEN OR SHORT CIRCUIT. AN X-RAY WAS TAKEN AND NO LEAD FRACTURES WERE FOUND IN THE LEAD OR EXTENSION. THERAPEUTIC SETTINGS WERE 3.6V, 120 PW, 240 RATE, AND C+, 0-. THE PATIENT WAS RESET TO A LOWER PULSE WIDTH. THE PATIENT¿S DOCTOR ADVISED TO CHANGE PROGRAMMING FROM GROUP B TO GROUPS C AND D TO ELIMINATE THE SIDE EFFECT. THERE IS NO SURGICAL INTERVENTION SUGGESTED FOR THE PATIENT.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION WAS RECEIVED FROM THE HCP VIA THE REP, REPORTING THAT THE HCP WAS ABLE TO PROGRAM THE PATIENT ON CONTACTS 0 AND 3. THE HCP REPORTED THAT THE PATIENT'S TREMORS WERE SUCCESSFULLY CONTROLLED AND THE PATIENT WAS DOING BETTER. THE HCP REPORTED THAT THE PATIENT WAS NO LONGER REPORTING SHOCKING SENSATIONS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REP, REPORTING THAT THE LEAD REPLACEMENT WAS SCHEDULED FOR (B)(6) 2017. THE REP REPORTED THAT THE HCP REPLACED THE LEFT SIDE LEAD AND EXTENSION. THE REP REPORTED WHILE CONNECTING THE NEW LEAD TO THE ORIGINAL EXTENSION, THE EXTENSION WAS DAMAGED AND THE HCP HAD TROUBLE REMOVING THE LEAD FROM THE EXTENSION. THE REP REPORTED THAT THE LEAD IMPEDANCES WERE IN NORMAL RANGE AFTER IMPLANT IN THE BRAIN, BUT AFTER IT WAS CONNECTED TO THE EXTENSION THE IMPEDANCES WERE HIGH. THE REP REPORTED THAT AFTER REPLACING THE EXTENSION, THE FINAL IMPEDANCES WERE IN THE FOLLOWING RANGES: IMPEDANCE FOR CONTACT 3 WERE OVER 40,000 OHMS IMPEDANCE FOR CONTACT 1 WERE 24,000 OHMS THE REP REPORTED THAT THE HCP DECIDED TO CLOSE AND PROGRAM ON THE "GOOD" CONTACTS.NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE INDICATING THE CAUSE OF THE SHOCKING WAS NOT DETERMINED AND THE FIRST CHANGE IN PROGRAMMING DID NOT RESOLVE THE ISSUE. THE PATIENT WAS SCHEDULED FOR A LEAD REPLACEMENT LATER THIS MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62840 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention