BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5964244 · Received September 20, 2016

    Report

    Report Number
    3004209178-2016-19287
    Event Type
    Injury
    Date Received
    September 20, 2016
    Date of Event
    February 10, 2016
    Report Date
    October 2, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM, OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387S-40, LOT# VA1174N, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE : PRODUCT ID 3387S-40 LOT# VA1174N, IMPLANTED: (B)(6)2016. PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# VA1174N IMPLANTED: (B)(6)2016 PRODUCT TYPE LEAD. DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES NO LONGER APPLY TO THIS EVENT MEDTRONIC, INC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE IMPLANT WAS INITIALLY PLACED TOO CLOSE TO THE PATIENT'S OPTIC NERVE AND SHE HAD A HARD TIME WAKING UP AFTER THE PROCEDURE DUE TO TOO MUCH ANESTHESIA; THE PATIENT WAS GROGGY. THE PATIENT THEN STATED THAT SHE THINKS SHE HEARD THE HEALTH CARE PROVIDER (HCP) STATE THAT THE LEAD MAY HAVE BEEN IMPLANTED TOO DEEP. IT WAS ALSO REPORTED THAT THEY WERE UNABLE TO FIND THE APPROPRIATE PROGRAMMING CAUSING THE PATIENT TO EXPERIENCE "SOME AWFUL SIDE EFFECTS"; THE PATIENT DID NOT ELABORATE ON THE SIDE EFFECTS. THE LEAD WAS REVISED AND PLACED IN THE CORRECT LOCATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT INDICATING THAT INITIALLY PATIENT NOTICED THEY HAD FLUID BEHIND THE INS WHICH WAS CAUSING PAIN AND DISCOMFORT. IT WAS STATED THAT THE HEALTH CARE PROFESSIONAL (HCP) WENT IN AND DRAINED THE FLUID BUT THEN IT JUST STARTED GETTING BIGGER ON THEIR CHEST. IT WAS NOTED THAT THE DEVICE DID NOT RUPTURE THROUGH THE SKIN. PATIENT NOTED THAT THEY WENT BACK TO THE HCP AND HAD A REVISION SURGERY. PATIENT STATED THAT THEY HAD DYSTONIA AND PULLS TO THE LEFT WHICH WAS WHY THEY HAD THE DEVICE IMPLANTED TO HELP MANAGE. PATIENT FEELS THE HCP SHOULD NOT HAVE MOVED THE INS TO THE LEFT SIDE SINCE THIS IS THE SAME SIDE PATIENT WOULD NEED DEFIBRILLATION THERAPY. PATIENT THINKS WHAT HAPPENED WAS WHEN THEY PULLED TO THE LEFT, IT PULLED ON THE BATTERY ITSELF AND THERE WAS A DISCONNECT TO THE LEAD GOING TO THE BRAIN. PATIENT IS ALSO EXPERIENCING A FIB AND THEY WERE UNSURE IF IT WAS RELATED TO THE DEVICE OR THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THERE WAS A PLACEMENT ERROR DONE BY A TECHNICIAN DURING IMPLANTATION SURGERY, WITH IT INQUIRED IF THERE WERE REPERCUSSIONS DUE TO THE MISTAKE AND WHAT PART OF THE BRAIN WAS EFFECTED. IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PLACED 7MM POSTERIOR AND HAD TO BE MOVED 7MM FORWARD. IT WAS SUGGESTED THAT THE PATIENT FOLLOW UP WITH THEIR HEALTHCARE PROFESSIONAL (HCP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614777 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention