BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3478694 · Received November 20, 2013

    Report

    Report Number
    3004209178-2013-21108
    Event Type
    Injury
    Date Received
    November 20, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 4, 2013
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 64002 LOT# N268906, IMPLANTED: 2012 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 3387S-40, LOT# V050275, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748240, SERIAL# (B)(4); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, SERIAL# (B)(4); PRODUCT TYPE LEAD PRODUCT ID 37651, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 64002 LOT# N268906, IMPLANTED: 2012 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 3387S-40 LOT# V050275, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748240, SERIAL# (B)(4); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, SERIAL# (B)(4); PRODUCT TYPE LEAD PRODUCT ID 37651, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 64002, LOT# N268906, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3387S-40, LOT# V050275, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748240, SERIAL# *(B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, SERIAL# *(B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROFESSIONAL HAD NOT SEEN THE PATIENT, HIS CT SCAN OR ANY OF HIS HOSPITALIZATION DETAILS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER. THE BATTERIES WERE REPLACED AND THEY WERE ABLE TO USE THE PATIENT PROGRAMMER. IT WAS NOTED THAT THE STIMULATOR WAS OFF. STIMULATION WAS TURNED BACK ON AND STIMULATION WAS LOWERED TO A DESIRED SETTING. THE PATIENT HAD GONE TO THE HOSPITAL ON THE FRIDAY PRIOR TO THIS REPORT BECAUSE HIS ¿CHEST WAS HURTING.¿ IT WAS NOTED THAT THEY THOUGHT THE STIMULATOR WAS THE PROBLEM. THE PATIENT WAS BREATHING BUT WAS NOT RESPONDING. STIMULATION WAS TURNED BACK ON AND THE PATIENT WAS AWAKE AND TALKING TO THE REPORTER. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS OFF. THE DEVICE NOT ON AT THE TIME OF THE EVENT. IT WAS NOTED THAT THE PATIENT HAD TURNED IT OFF RIGHT BEFORE BEING HOSPITALIZED ACCIDENTLY. NO CAUSE WAS DETERMINED AS TO WHAT THE CAUSE OF THE PATIENT'S SYMPTOMS WAS. IT WAS FURTHER NOTED THAT WHEN IT WAS NOTICED THAT THE DEVICE WAS OFF ABOUT 3 DAYS AFTER HOSPITALIZATION, THE PATIENT WAS BACK TO NORMAL WITHIN A FEW HOURS OF THE DEVICE BEING TURNED BACK ON. PATIENT WAS DOING VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602737 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization