BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3168149 · Received June 13, 2013

    Report

    Report Number
    3004209178-2013-10300
    Event Type
    Injury
    Date Received
    June 13, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 23, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3389S-40 LOT# V090728, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID:7482A40 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT THE STIMULATOR MAY HAVE DEPLETED PREMATURELY. THE STIMULATOR LASTED FOR 9 MONTHS. THE PATIENT PLANNED TO HAVE THE STIMULATOR REPLACED IN (B)(6) 2013. THE PHYSICIAN DID TESTING ON THE STIMULATOR AT THE LAST APPOINTMENT, BUT THE PATIENT WAS NOT GIVEN THE RESULTS. THE PATIENT WAS LETHARGIC AND COULDN¿T MOVE ANYTHING BUT ONE HAND. OF NOTE, IT WAS LATER STATED THAT THE PATIENT¿S BASELINE WAS THAT HE COULDN¿T MOVE HIS BODY AND COULDN¿T SPEAK BUT HIS MIND WAS GOOD. IT WAS RECOMMENDED THE STIMULATOR BE RETURNED FOR ANALYSIS. THE PHYSICIAN FELT THE BATTERY DEPLETED PREMATURELY. THERE WERE NO ABNORMAL IMPEDANCES. THE PATIENT WAS HOSPITALIZED DUE TO THE EVENT, BUT DETAILS WERE NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED. IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267702 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization