BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2689031 · Received August 9, 2012

    Report

    Report Number
    3004209178-2012-06681
    Event Type
    Malfunction
    Date Received
    August 9, 2012
    Date of Event
    July 10, 2012
    Report Date
    July 12, 2012
    Manufacturer
    MDT 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 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387S-40, LOT# V992702, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V989565, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED DURING A SURGICAL PROCEDURE ON (B)(6) 2012. IT WAS NOTED THAT THERE WERE HIGH IMPEDANCES ASSOCIATED WITH THE IMPLANTED DEVICE. THESE IMPEDANCE VALUES WERE REPORTED AS GREATER THAN 40,000 OHMS FOR THE "RIGHT BRAIN COMBOS" AND ABOUT 17,000 OHMS FOR THE "LEFT BRAIN COMBOS." THE MANUFACTURING REPRESENTATIVE STATED THAT "BOTH ELECTRODE 3 IN THE LEFT BRAIN AND ELECTRODE 11 ON THE RIGHT BRAIN HAD HIGH IMPEDANCE MEASUREMENTS." IT WAS NOTED THAT ALL COMBINATIONS WITH THESE CONTACTS SHOWED HIGH IMPEDANCES AS WELL. IT WAS FURTHER NOTED THAT THE SURGEON "NOTICED DAMAGE TO THE RIGHT LEAD WHEN REMOVING THE LEAD CAP PROTECTOR AND THEORIZED THAT THIS MIGHT HAVE BEEN THE ISSUE ON BOTH SIDES BECAUSE THE PROTECTOR SCREWED INTO THE 3 AND 11 CONTACTS." THE MANUFACTURING REPRESENTATIVE STATED THAT THEY "PLANNED TO AVOID USING THE 3 AND 11 CONTACTS." IT WAS FURTHER NOTED THAT THE NEUROLOGIST WOULD BE NOTIFIED OF THE ISSUE. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR