BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4230542 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21029
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V648226, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT DOING WELL, COULD NOT HAVE ANYTHING TOUCH HIS SKIN, COULD NOT EAT AND COULD NOT SLEEP. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED ON (B)(6) 2014. THE INS HAD DIED ABOUT 2 MONTHS PRIOR TO THE DATE OF THIS REPORT WHICH WAS THE SAME THAT THE PATIENT NOT BEING ABLE TO HAVE ANYTHING TOUCH HIS SKIN HAD STARTED. THE INS HAD ONLY BEEN IN ABOUT 3.5 YEARS AND THE PATIENT HAD BEEN UNDER THE ASSUMPTION THAT IT WOULD BE ABOUT 6 YEARS. NO OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715574 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention