BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2923150 · Received January 18, 2013

    Report

    Report Number
    3004209178-2013-00771
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 31, 2012
    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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMTIANT PRODUCT: PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 64002 LOT# N322773, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ADAPTER PRODUCT ID, 3387S-40 LOT# V099194, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387S-40 LOT# V099194, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS FOUND TO BE OFF AT TWO DIFFERENT TIMES. THE FIRST TIME WAS DURING THE DAY ON (B)(6) 2012. THE PATIENT INTERROGATED THE INS WITH THE PATIENT PROGRAMMER AND FOUND THE INS TO BE OFF. SHE TURNED IT BACK ON AND ¿THINGS WERE OKAY.¿ THAT NIGHT SHE WOKE UP IN THE MIDDLE OF THE NIGHT AND WAS UNABLE TO GET TO THE BATHROOM IN TIME, URINATING ALL OVER THE PLACE. WHILE IN THE EMERGENCY ROOM, THE PATIENT RECEIVED A COMPUTED TOMOGRAPHY SCAN WHICH SHOWED NO ACUTE CHANGES. ON (B)(6) 2012, THE HEALTH CARE PROVIDER FOUND THE SETTINGS TO BE ON, BUT THE RIGHT STIMULATOR TO BE OFF. WHEN THE PATIENT TRIED TO PROGRAM THE DEEP BRAIN STIMULATORS, SHE WAS UNSURE WHAT SHE WAS DOING BECAUSE OF ICON MESSAGES THAT APPEARED. THE ICONS ON THE PATIENT PROGRAMMER WERE REVIEWED AND IT WAS DETERMINED THAT THE PATIENT PROGRAMMER DISPLAYED A LOW BATTERY SIGNAL. A NEW SET OF BATTERIES WERE PLACED IN THE PATIENT PROGRAMMER WHICH RESOLVED THIS PROBLEM. THE BEHAVIOR OF THE STIMULATORS WAS AS EXPECTED AND THE BEHAVIOR OF THE PROGRAMMER WAS BACK TO NORMAL. IT WAS NOTED THAT THE PATIENT WAS NOT HOSPITALIZED. AT THE END OF THE PROGRAMMING SESSION, THE PATIENT WAS ABLE TO AMBULATE WITHOUT DIFFICULTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A RETURN OF SYMPTOMS. THE REPORTER STATED THAT THE DEVICE "WENT OFF" ON (B)(6) 2012 DURING THE NIGHT. THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2012 AND "NO ONE KNEW ANYTHING." THE PATIENT SAW HER HEALTH CARE PROVIDER (HCP) ON (B)(6) 2012. IT WAS REPORTED THAT THE DEVICE ON THE RIGHT SIDE WAS AT 0 AND IT WAS SUPPOSED TO BE AT 3.4. IT WAS NOTED THAT THE HCP COULD NOT EXPLAIN WHY THAT HAD HAPPENED. IT WAS REPORTED THAT THIS COULD BE SEEN ON THE CLINICIAN PROGRAMMER, BUT THE PATIENT COULDN'T SEE IT ON "HER MACHINE." THE REPORTER STATED THAT THE PATIENT HAD A RETURN OF SYMPTOMS ON THE RIGHT SIDE AND "WAS WALKING SIDEWAYS," "COULDN'T GET HER RIGHT SIDE TO COME UP" AND "KNEW SOMETHING WAS WRONG." IT WAS ALSO NOTED THAT THE PATIENT COULDN'T FEED HERSELF OR SIT UP STRAIGHT. THE HCP TURNED THE DEVICE BACK TO 3.4. IT WAS NOTED THAT THIS WAS THE FIRST TIME THIS OCCURRED. THE PATIENT PLANNED TO CONTACT A DIFFERENT HCP ABOUT THE ISSUE ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27379 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization