BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6870211 · Received September 15, 2017

    Report

    Report Number
    3004209178-2017-19461
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    September 13, 2017
    Report Date
    November 20, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761071
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37603 (B)(4) IMPLANTED: (B)(6)2017 PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM, OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3708660 (B)(4) PRODUCT TYPE EXTENSION ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. CONCLUSION CODE 92 NO LONGER APPLIES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS (SERIAL #(B)(4) FOUND THE INS WAS FUNCTIONALLY OK, WITH INSIGNIFICANT ANOMALIES. ANALYSIS OF THE EXTENSION (SERIAL # (B)(4)) FOUND NO ANOMALIES. FDC CODE 71 HAS REPLACED FDC CODE 11. FDR CODES 213, 825 (INS) AND 476 (EXTENSION) HAVE REPLACED FDR CODE 3221. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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

    THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCES WAS STILL UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT IMPLANTED FOR OTHER DEEP BRAIN STIMULATION (DBS) AND MOVEMENT DISORDERS. IT WAS REPORTED THAT HIGH IMPEDANCES WERE MEASURED DURING AN INS AND EXTENSION REVISION PROCEDURE. THE HIGH IMPEDANCES WERE ON CONTACT PAIR 2-3 BETWEEN 5000 AND 8000 OHMS ON THE NEW INS AND EXTENSION. THE EXTENSION WAS RE-SEATED, BUT DID NOT RESOLVE THE ISSUE. A NEW EXTENSION WAS USED AND THE OLD INS WAS ALSO CONNECTED; HOWEVER, THERE WERE STILL HIGH IMPEDANCES ON PAIR 2-3. THE LEAD WAS CHECKED WITH TWIST-LOCK, AND THE IMPEDANCE WAS NORMAL. THE PHYSICIAN CLOSED UP SINCE 2-3 WAS NOT SUED FOR THERAPY. NO MEDICAL SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649630 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761071

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR