BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2945746 · Received February 6, 2013

    Report

    Report Number
    3007566237-2013-00383
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# VA02Y9Y, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A POSSIBLE OPEN CIRCUIT. THE REPORTER STATED THAT THE PATIENT WAS AT THE CLINIC FOR INITIAL PROGRAMMING AND THERE WERE HIGH IMPEDANCE VALUES. IT WAS REPORTED THAT ELECTRODE PAIRS WITH ELECTRODE 10 WERE ON THE HIGH SIDE, AROUND 8000-9000 OHMS. IT WAS NOTED THAT OTHER PAIRS WERE IN THE EXPECTED RANGE, AND MOST VALUES WERE BELOW 5000 OHMS. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED CONFIRMED THAT THE HIGH IMPEDANCES WERE OBSERVED AT INITIAL PROGRAMMING OF THE IMPLANTABLE NEUROSTIMULATOR (INS). HIGH IMPEDANCE VALUES MEASURED WERE CASE TO ELECTRODE #10 = 9547 OHMS, ELECTRODE #8 TO #10 = 8011 OHMS, AND ELECTRODE #10 TO #11 = 9308 OHMS. REPROGRAMMING WAS PERFORMED ON (B)(6) 2013 WHERE IT WAS NOTED THAT THE ELECTRODES COMBINATIONS WITH HIGH IMPEDANCES WERE AVOIDED WHEN PROGRAMMING THE PATIENT. RESULTS OF THERAPY IMPEDANCES MEASURED ON FOLLOW UP ON (B)(6)2013 WERE AS FOLLOWS: RIGHT (PROGRAMMED CASE POSITIVE, ELECTRODE #8 NEGATIVE) = 1206 OHMS; LEFT (PROGRAMMED CASE POSITIVE, ELECTRODE #0 NEGATIVE) = 1608 OHMS. THE PATIENT WAS THEN SEEN ON (B)(6) 2013 AT WHICH TIME IT WAS OBSERVED THAT IMPEDANCES WERE WITHIN NORMAL LIMITS WHEN TAKEN AT 1.5 VOLTS. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE IMPEDANCES MEASUREMENTS OF 10,000 OHMS (AT DEFAULT SETTINGS) AND 7,500 OHMS (AT 3 VOLTS) WITH THE 8 AND 10 ELECTRODE PAIR COMBINATION. IT WAS STATED THAT THE HEALTHCARE PROVIDER (HCP) WAS DOING INTERLEAVING (STN 1 WAS 10+, 11-; STN 2 8-, 10+). IT WAS ALSO STATED THAT THE OTHER IMPEDANCES WERE AS FOLLOWS: C/10 6,700 OHMS, 9/10 6,600 OHMS AND 10/11 6,000. IT WAS MENTIONED THAT ELECTRODE SHOULD NOT BE USED, BUT COULD BE AN ANODE IF NECESSARY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE CAUSE OF THE EVENT WAS THE LEAD ELECTRODE #10 WAS NOT VIABLE. IT WAS STATED THE IMPEDANCE MEASUREMENTS ON COMBINATIONS WITH ELECTRODE 10 WERE GREATER THAN 6000 OHMS. REPORTEDLY, THE PATIENT¿S DEVICE WAS REPROGRAMMED ON (B)(6) 2013 TO AVOIDELECTRODE 10 AND IT WAS STATED ALL OTHER IMPEDANCES WERE WITHIN NORMAL LIMITS. IT WAS NOTED THERE WERE NO SIGNS OR SYMPTOMS RELATEDTO THE EVENT AND THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE PATIENT¿S OUTCOME WAS REPORTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50480 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1