BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 5363051 · Received January 13, 2016

    Report

    Report Number
    3004209178-2016-00419
    Event Type
    Death
    Date Received
    January 13, 2016
    Date of Event
    May 2, 2012
    Report Date
    June 2, 2016
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3389S-40, LOT# V925809, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID :3389S-40, LOT# V878959, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 37601 (LOT # (B)(4)) SHOWED INS FUNCTIONALLY OKAY; INSIGNIFICANT ANOMALIES. NO SIGNIFICANT ANOMALY. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: : PRODUCT ID 3389S-40, LOT# V925809, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V878959, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    A PATIENT IMPLANTED FOR PARKINSONS DUAL REPORTED THEY WERE DIFFICULT TO UNDERSTAND AND THEY COULDN'T SPEAK VERY WELL. THE PATIENT WAS HAVING A "HECK OF A TIME" AND IT HAD SEEMED LIKE "NONE OF THE HEALTH CARE PROFESSIONALS (HCP) COULD HELP THE PATIENT WITH THE PROGRAMMING OF THEIR DEVICE." THE PATIENT STATED HE HAD BEEN HAVING ISSUES WITH PROGRAMMING SINCE IMPLANT. THE PATIENT HAD SEEN SIX NEUROLOGISTS SO FAR, AND ALL OF THE DIFFERENT PROVIDERS TOLD HIM HE DIDN'T HAVE PARKINSONS'S. ONE HCP THOUGHT THE PATIENT MAY HAVE SOME SORT OF VIRUS. THE PATIENT MENTIONED HE WAS A TOLD BY ONE OF THE HCP'S THEY WERE SURPRISED THE PATIENT WAS IMPLANTED WITH THE DEVICE BECAUSE OF HOW MANY MEDICATIONS THE PATIENT WAS ON. ON (B)(6) 2016 THE PATIENT'S WIFE REPORTED THE PATIENT PASSED AWAY ON (B)(6) 2015. THE PATIENT'S CONDITION WORSENED IMMENSELY AFTER THE DEEP BRAIN STIMULATOR (DBS) PROCEDURE AND THE PATIENT'S WIFE WAS AFRAID THE PROCEDURE SHOULDN'T HAVE BEEN DONE IN THE FIRST PLACE. THE PATIENT'S LAST NEUROLOGIST FELT THE PATIENT WAS MISDIAGNOSED WITH PARKINSON'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22334 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death