BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4242452 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21280
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389S-40, LOT# VA0KHVQ, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-40, LOT# VA0KHVQ, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD SYMPTOMS OF RIGIDITY, FREEZING GAIT, BRADYKINESIA, AND PAIN. THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DEPLETION WAS CONSIDERED PREMATURE AND THE DEVICE WAS REPLACED IN (B)(6) 2014. THE INS WAS PROGRAMMED IN CONTINUOUS MODE. THE HEALTHCARE PROFESSIONAL (HCP) STATED THERE WAS A PROBLEM WITH THE INS THAT REQUIRED REPLACEMENT. AN OPEN CIRCUIT AND BATTERY LOSS WAS DETECTED AND THE INS DIED WITHIN TWO MONTHS OF IMPLANT. THE PATIENT¿S OTHER INS WAS DOING FINE AND THERE WAS NO TRAUMA OR INJURY TO EXPLAIN THE PROBLEM. AT THE TIME OF THIS REPORT THE PATIENT HAD NOT RECOVERED AND THE SYMPTOMS/ISSUE WERE ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTIVE REPLACEMENT INDICATOR (ERI) APPEARED SATURDAY. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED IN (B)(6) 2014 AND STIMULATION WAS TURNED ON IN (B)(6) 2014. THE PATIENT STATED THEIR HEALTHCARE PROFESSIONAL TOLD THEM THAT THERE SETTINGS WERE LOW. FOLLOW UP WITH THE PATIENT INDICATED THE INS WAS REPLACED DUE TO BEING ¿DEFECTIVE.¿ NO SYMPTOMS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT THOUGHT IT WAS A WIRING PROBLEM WHERE IT PULLED LOOSE AND THAT CAUSED THE IMPLANTABLE NEUROSTIMULATOR (INS) TO DEPLETE RAPIDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726986 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention