BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2943336 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01283
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 15, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748240 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 37754 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID: 37092 LOT# 233640001, IMPLANTED: 2009 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 3389-40 LOT# J0519177V, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3389-40 LOT# J0519177V, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT USED TO HAVE ALL OF THEIR CONTACTS ¿LIT UP WITH HIGH VOLTAGES.¿ REPORTEDLY, THE PATIENT HAD TO RECHARGE FOR LONGER PERIODS OF TIME EACH DAY IN (B)(6) 2012 AND (B)(6) 2013. IT WAS STATED THE IMPEDANCE READINGS SHOWED A SHORT BETWEEN 0 AND 1, 0 AND 3, AND 1 AND 3 ON THE PATIENT¿S LEFT LEAD. IT WAS REPORTED THE PATIENT HAD SURGERY AND INTRAOPERATIVE TESTING OF THE LEAD SHOWED A SHORT ON 1 WHICH WAS 144 OHMS. IT WAS NOTED THE PATIENT WAS NOT A CANDIDATE FOR ADDITIONAL SURGERIES SO THE LEFT SIDE WAS SHUT OFF AND THE PATIENT HAD NOT BEEN DOING AS WELL SINCE. THE DAY OF REPORT, IMPEDANCE TESTING WAS DONE AND THE LEFT SIDE SHOWED NORMAL IMPEDANCE RANGE. IT WAS NOTED OPTIONS FOR TURNING THE PATIENT¿S LEFT SIDE BACK ON WERE DISCUSSED. REFERENCE MANUFACTURER REPORT # 3004209178-2013-06447 FOR INFORMATION PREVIOUSLY REPORTED ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXPLORATORY SURGERY ON THE DAY OF THE REPORT IT WAS DISCOVERED THAT THE LEFT STIMULATION LEAD HAD A SHORT-CIRCUIT. IT WAS BEING DETERMINED IF THE PATIENT WAS ABLE TO UNDERGO A BRAIN SURGERY TO REPLACE THE LEAD. NO DECISION WAS KNOWN AT THE TIME OF THE REPORT. TWO DAYS LATER, IT WAS STATED THAT THERE HAD BEEN NO INTERVENTIONS TAKEN TO DATE. PATIENT'S THERAPY HAD NOT BEEN AS EFFECTIVE AS PREVIOUSLY. OPTIONS WERE BEING CONSIDERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD SURGERY A WHILE AGO TO ¿TRY TO FIND CHANGES IN THE IMPEDANCE VALUE¿ OF THE DEVICE AND IT ¿DIDN¿T REALLY WORK¿ SO ONE SIDE OF THE DEVICE WAS SHUT OFF. IT WAS NOTED THAT THE PATIENT HAD HAD A MEETING WITH A NEUROLOGIST AND A MANUFACTURING REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT WANTED TO SPEAK TO THE MANUFACTURING REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47935 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R