BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4977419 · Received August 6, 2015

    Report

    Report Number
    3004209178-2015-15589
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389S-40, LOT# V038036, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V012773, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE REPORTED THAT BEFORE AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT FOR NORMAL BATTERY DEPLETION AN OPEN CIRCUIT, >40,000 OHM IMPEDANCE READING WAS DETECTED BETWEEN ALL COMBINATIONS WITH AND #2 ELECTRODE. IN ADDITION, THE #0 AND #3 ELECTRODE COMBINATION SHOWED A SHORT CIRCUIT IMPEDANCE OF 8 OHMS. THE IMPEDANCE ISSUES WERE NOTED TO NOT HAVE IMPACTED THE PATIENT'S THERAPEUTIC SETTINGS OR CAUSED PREMATURE BATTERY DEPLETION. AFTER CONNECTION OF THE NEW INS IMPEDANCES WERE TESTED INTRAOPERATIVELY AND IT WAS FOUND THAT THE OPEN CIRCUITS HAD RESOLVED; THE CASE AND #2 ELECTRODE COMBINATION HAD AN IMPEDANCE OF 1,000 OHMS. HOWEVER, THE IMPEDANCE BETWEEN ELECTRODE #0 AND #3 WAS STILL SHOWING 8 OHMS. THIS ISSUE WAS NOT RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED AND THE PATIENT OUTCOME WAS DESCRIBED AS "ALIVE - NO INJURY." NO POTENTIAL CAUSES OF THE EVENT WERE PROVIDED, BUT IT WAS STATED THAT THE HEALTH CARE PROVIDER (HCP) WOULD NOT HAVE ANY MORE INFORMATION FOR MEDTRONIC, SO FURTHER FOLLOW-UP IS NOT POSSIBLE. INDICATIONS FOR USE: PARKINSONS DUAL, MOVEMENT DISORDERS REFER TO MANUFACTURER REPORT 3004209178-2015-15588.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520384 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR