BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3030890 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04474
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 13, 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
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# V829968, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# VA01UJ1, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V829968, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3387S-40, LOT# V829968, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# VA01UJ1, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V829968, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3387S-40, LOT# V829968, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# VA01UJ1, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V829968, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A DECREASE IN THERAPEUTIC EFFECT. IT WAS STATED THAT THE ORIGINAL LEAD WAS 'NOT WORKING GREAT' FOR THERAPEUTIC BENEFIT. THE PATIENT HAD A NEW (SECOND) LEAD IMPLANTED IN THE SAME LOCATION AND THE ORIGINAL WAS LEFT IN PLACE AND REMAINED CONNECTED. IT WAS ALSO STATED THAT ONLY THE NEW LEAD WAS USED OVER THE COUPLE MONTHS PRIOR TO REPORT. IT WAS NOTED THAT WITH ONLY USING THE NEW LEAD THE PATIENT WAS 'GETTING BENEFIT, BUT NOT AS MUCH AS THEY EXPECTED' SO THE PATIENT'S NURSE WANTED TO TRY TO ACTIVATE THE NEW AND OLD LEAD AT THE SAME TIME AND LEAD RECONFIGURATION WAS DISCUSSED. NO FURTHER INFORMATION WAS KNOWN AT THE TIME OF REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE HEALTHCARE PROVIDER WAS ABLE TO PROGRAM BOTH LEADS SUCCESSFULLY AND IT WAS HELPING WITH THE PATIENT¿S TREMORS. IT WAS NOTED THE PATIENT HOPED IT WOULD HELP MORE. IT WAS ALSO NOTED THAT THE IMPEDANCES WERE GOOD FOR BOTH LEADS.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED PATIENT HAD RIGHT LEG WEAKNESS. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133592 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention