BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4433888 · Received January 20, 2015

    Report

    Report Number
    3004209178-2015-00954
    Event Type
    Malfunction
    Date Received
    January 20, 2015
    Date of Event
    December 30, 2014
    Report Date
    December 30, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# V093181, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# V093181, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE AND THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY VOLTAGE LEVEL READ AT 2.82V. THEY SAW THE ERI ON THE PATIENT PROGRAMMER THE WEEK PRIOR TO REPORT. ON THE DAY OF REPORT THE INS WAS READ WITH THE CLINICIAN PROGRAMMER AND AT THAT TIME THE INS WAS OFF. ERI AND POWER ON RESET (POR) CODES SHOWED ON THE CLINICIAN PROGRAMMER SCREEN UPON INTERROGATION. THE PATIENT RECENTLY HAD SURGERY BUT CAUTERY WAS NOT USED. A SCREW WAS REMOVED FROM HER FOOT AND THE PROCEDURE WAS NON-INVASIVE. THE INS CURRENTLY HAD A BATTERY VOLTAGE OF 2.65V. IT WAS NOTED THE OTHER INS WAS CLOSE TO ERI AND WITH SIMILAR SETTINGS. IT WAS FURTHER REPORTED IT WAS UNKNOWN WHAT CODE ACCOMPANIED THE POR SINCE IT WAS CLEARED BEFORE THEY COULD READ IT. THE CAUSE OF THE POR WAS UNKNOWN. THE PATIENT HAD NO THERAPY AND INTERVENTIONS INCLUDED TURNING THE DEVICE BACK ON. THE PATIENT RECEIVED GOOD THERAPY. NO INTERVENTIONS 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
    45027 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR