BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 6563037 · Received May 12, 2017

    Report

    Report Number
    3004209178-2017-10178
    Event Type
    Injury
    Date Received
    May 12, 2017
    Date of Event
    April 19, 2017
    Report Date
    May 30, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387S-40, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. 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

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3387S-40, LOT# V865879, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V093181, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2017, PRODUCT TYPE LEAD .PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE :IMPLANTABLE NEUROSTIMULATOR. PATIENT CODE (B)(4) NO LONGER APPLIES, (B)(4) HAS REPLACED IT.

    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 MANUFACTURING REPRESENTATIVE ABOUT A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR. IT WAS REPORTED THAT THE PATIENT WAS HAVING A LEAD REVISION SURGERY. DURING THE DISSECTION OF TISSUE WITH A RADIOFREQUENCY ELECTRICAL ABLATION TOOL THE PATIENT REPORTED FEELING A BRIEF SENSATION IN THEIR RIGHT ARM. THE SURGEON STOPPED USING THE DEVICE IMMEDIATELY AND SWITCHED TO USING ANOTHER TOOL. THE PATIENT¿S LEAD WAS EXPLANTED. NO COMPLICATIONS OR FURTHER COMPLICATIONS WERE REPORTED. [REFER TO MANUFACTURER REPORT #3004209178-2017-10177 FOR DETAILS PERTAINING TO THE REPORTABLE RELATED EVENT.]

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP WHO REPORTED THAT THE LEAD REVISION WAS PERFORMED BECAUSE THE LEAD WAS MECHANICALLY IMPAIRED DUE TO SUSPECTED FRACTURE AND A LOSS OF THERAPY EFFICACY. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344902 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention