BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5065119 · Received September 9, 2015

    Report

    Report Number
    3004209178-2015-17608
    Event Type
    Injury
    Date Received
    September 9, 2015
    Report Date
    August 13, 2015
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708695, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708695, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# VA01MBS, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V992702, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 37092, LOT# 337540001, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL OF THE CLINICAL STUDY REPORTED THE DEVICE WAS NEAR BATTERY DEPLETION AND WAS REPLACED AS AN INTERVENTION. THE HEALTH CARE PROFESSIONAL INDICATED THE BATTERY DEPLETION WAS NORMAL. THE EVENT WAS CONSIDERED RESOLVED AT THE TIME OF REPORT AND NO SIGNS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION FROM THE PATIENT'S ATTORNEY REPORTED AT THEIR REGULAR VISIT TO THEIR PHYSICIAN THE PATIENT COMPLAINED OF PARKINSON'S SYMPTOMS RETURNING AND THAT THEIR STIMULATOR DID NOT SEEM TO BE WORKING AS WELL AS BEFORE. THE PATIENT'S CONDITION CONTINUED TO DECLINE AND THEIR SYMPTOMS CONTINUED TO INCREASE INCLUDING RIGIDITY AND SEVERE AND CONTINUOUS PAIN IN THEIR LEGS, BACK, AND SHOULDERS. AT THE PATIENT'S NEXT VISIT THE PHYSICIAN DETERMINED THAT THE INCREASED SYMPTOMS WERE THE RESULT OF DIMINISHING POWER AVAILABLE FROM THE STIMULATOR AND THAT THE BATTERY WAS SERIOUSLY FAILING. THE PHYSICIAN SUGGESTED DEVICE REPLACEMENT DUE TO RAPID RATE OF DECLINE. ULTIMATELY THE PATIENT HAD THEIR STIMULATOR REPLACED. THE STIMULATOR LASTED ONE YEAR TEN MONTHS AND THIRTEEN DAYS WHICH WAS NOTED TO BE "A SIGNIFICANT DEVIATION OF ONE YEAR AND TWO MONTHS FROM THE SHORTEST THREE YEAR AVERAGE STATED ON WEBSITE, IN LITERATURE, AND BY SALES REPRESENTATIVES. THIS WAS NOTED AS "EARLY FAILURE" AND EXTREMELY SHORT LIFE BY THE ATTORNEY. THE HEALTH CARE PROFESSIONAL AND ATTORNEY ALLEGED DIFFERENT KINDS OF BATTERY DEPLETION THEREFORE IT WAS UNCLEAR IF THE BATTERY DEPLETION WAS NORMAL OR ABNORMAL. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597404 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention