BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4333956 · Received December 16, 2014

    Report

    Report Number
    3004209178-2014-24040
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Report Date
    November 24, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37612 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387S-40, LOT# V011138, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 64001, LOT# N251181, IMPLANTED: 2011 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 3387-40, LOT# J0214131V, IMPLANTED: 2002 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7495LZ66, SERIAL# (B)(4), IMPLANTED: 2002 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 64001, LOT# N251185, IMPLANTED: 2011 (B)(6); PRODUCT TYPE ADAPTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. THE CAUSE OF THE EVENT WAS NOT DETERMINED AND IT WAS UNKNOWN IF IT WAS DEVICE RELATED. THE PATIENT¿S NEXT APPOINTMENT WAS SCHEDULED FOR 2015 (B)(6). IT WAS REPORTED THE IMPEDANCES FOR BOTH THE LEFT AND RIGHT IMPLANTABLE NEUROSTIMULATORS (INS) WERE NORMAL. A SHUNT SERIES WAS OBTAINED IN (B)(6) 2014. THERE WAS A SMALL KINK OF THE WIRE OF THE LEFT DEEP BRAIN STIMULATOR (DBS) APPROXIMATELY 1.3CM FROM THE LEAD CONNECTOR. THE PATIENT¿S NEXT APPOINTMENT WAS SCHEDULED FOR 2015 (B)(6). NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822558 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1