BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2961913 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02650
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 30, 2013
    Report Date
    August 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37085-60, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V194124, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    THE AWARE DATE FOR THE SUPPLEMENTAL MANUFACTURER'S REPORT 3004209178-2013-02650 WAS LISTED AS 2013 (B)(6). THE ACTUAL AWARE DATE OF THE ADDITIONAL INFORMATION WAS 2013 (B)(6). THIS RESULTED IN THE MANUFACTURER'S REPORT APPEARING LATE THOUGH IT WAS ACTUALLY SENT ON TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SUCCESSFUL ROUTINE REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) THE PATIENT WAS AWOKEN FROM ANESTHESIA AND CARDIAC FUNCTIONING WAS NOTED TO BE ABNORMAL BY THE OR STAFF. THE PATIENT WAS TAKEN TO THE CRITICAL CARE UNIT AND HAD UNDERGONE A MYOCARDIAL INFARCTION. HOSPITAL STAFF INDICATED THAT THE PATIENT HAD SIGNS OF EXISTING CARDIOVASCULAR ISSUES THAT WOULD NECESSITATE BYPASS SURGERY, WHICH WAS LIKELY GOING TO TAKE PLACE THE FOLLOWING DAY. THE IMPLANTED EQUIPMENT REMAINED INTACT AND IT WAS BELIEVED TO BE FULLY FUNCTIONAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPANY REPRESENTATIVE THAT REPORTED THE PATIENT WAS "DOING WELL" AND HAD NOT EXPERIENCED ANY FURTHER HEALTH PROBLEMS. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS SAID TO BE FUNCTIONING PROPERLY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64848 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention