BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4966301 · Received August 4, 2015

    Report

    Report Number
    3004209178-2015-14634
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED:(B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V015069, IMPLANTED:(B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED:(B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V021705, IMPLANTED:(B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTH CARE PROVIDER (HCP) REPORTED THAT A CT SCAN OF THE PATIENT'S HEAD AND BLOOD WORK WAS DONE. THE PATIENT HAD FALLEN AND HIT THEIR HEAD. THE PATIENT DID NOT HAVE A STROKE AND THEY SYMPTOMS HAD RESOLVED.

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER (HCP) REPORTED VIA THE COMPANY REPRESENTATIVE THAT THERE WAS A ¿PATIENT WITH A STROKE.¿ IT WAS LATER STATED THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL ON (B)(6) 2015 WITH ¿STROKE LIKE SYMPTOMS¿ AND THEY WANTED THE COMPANY REPRESENTATIVE TO COME AND CHECK THE DEVICE TO RULE THAT OUT AS A POSSIBLE PROBLEM. THERAPY IMPEDANCE WAS CHECKED AND ALL VALUES WERE WITHIN NORMAL RANGE. IN ADDITION, THE BATTERY HAD BEEN IN FULL TIME USE SINCE THE PREVIOUS (B)(6), AND THE PATIENT REPORTEDLY CHARGED THEIR BATTERY EVERY OTHER DAY AND KEPT IT ABOVE THE 50% RANGE. NO INTERVENTIONS/ACTIONS WERE NOTED TO HAVE BEEN TAKEN TO RESOLVE THE ISSUE, BUT IT WAS UNKNOWN IF THE ISSUE HAD RESOLVED. IT REMAINED UNKNOWN WHAT LED TO THE EVENT OR HOW THE ISSUE WAS IDENTIFIED. FURTHER FOLLOW-UP FOR DIAGNOSTICS, ACTIONS/INTERVENTIONS, AND PATIENT OUTCOME IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. INDICATIONS FOR USE: PARKINSONS DUAL MOVEMENT DISORDERS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506389 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| O