BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3233912 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11972
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 17, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 64002 LOT# N256795, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ADAPTER PRODUCT ID 37642 SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387S-40 LOT# V067713, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# V060436, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 7482A51 SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 748951 SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S BATTERY WAS DOWN TO 2.58 VOLTS(V) ON (B)(6) 2013 AND HAD BEEN IMPLANTED FOR TWO YEARS. IT WAS ALSO REPORTED, THE ELECTIVE REPLACEMENT INDICATOR (ERI) HAD BEEN REACHED ON THE PATIENT PROGRAMMER. IT WAS NOTED, THE BATTERY DROPPED FROM 2.59V TO 2.58V IN ONE DAY. THE PATIENT HAD AN APPOINTMENT WITH THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2013. IT WAS LATER REPORTED THE CAUSE OF THE EVENT WAS PREMATURE ERI AND REPROGRAMMING ON (B)(6) 2013 CONFIRMED LOW BATTERY. BATTERY REPLACEMENT OCCURRED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335975 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention