BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3622798 · Received February 11, 2014

    Report

    Report Number
    3004209178-2014-02816
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Report Date
    January 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-28, LOT# V193397, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-28, LOT# V193397, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-28, LOT# V193397, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE HAD HIGH IMPEDANCES. THE PATIENT PRESENTED TO HER CLINIC WITHOUT AN APPOINTMENT. THE DEVICE WAS INTERROGATED AND AN IMPEDANCE ISSUE WAS FOUND AT CONTACT 10 (>40, 000 OHMS). CONTACT 10 WAS SHOWING AS AN OPEN CIRCUIT. THE PATIENT WAS NOT PROGRAMMED WITH THAT CONTACT. ADDITIONALLY, IT WAS STATED THAT THE PATIENT HAD A HISTORY OF ¿IFFY¿ HIGH IMPEDANCES. IT STARTED AFTER THE LAST STIMULATOR REPLACEMENT WITH CONTACT 8, WHICH RESOLVED AFTER A WHILE AND REAPPEARED INTERMITTENTLY AROUND 20,000 OHMS. CONTACT 8 WAS NOT IN USE EITHER. THERE WERE NO FALLS. A SKULL AND NECK X-RAY DONE THE DAY OF THE REPORT WERE NEGATIVE AND THE PATIENT WAS RECEIVING GOOD THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THAT THIS WAS NOT A NEW PROBLEM AND WAS NOT AN ACTIVE ELECTRODE. ABNORMAL IMPEDANCES MEASUREMENTS WERE PREVIOUSLY STATED. NO SURGICAL INTERVENTION HAD OCCURRED. THERE WERE NO PATIENT SYMPTOMS. PATIENT HAD NOT REQUIRED HOSPITALIZATION AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89693 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR