BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4111287 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17573
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# V061739, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 3389-40, LOT# J0301149V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS EXPLANTED AND DISCARDED. IMPEDANCE TESTING WAS PERFORMED BUT THE SURGEON INDICATED THE LEAD WAS BROKEN. THE PATIENT'S OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED WITH THE REPLACEMENT AND THE CAUSE REMAINED UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS BROKEN. AN IMPEDANCE TEST WAS PERFORMED AND TWO COMBINATIONS WERE FOUND HIGH: CASE AND 0 WAS 4,879 OHMS AND 0 AND 3 WAS 4,171 OHMS. THE LEAD REMAINED IMPLANTED AS THE SURGEON WANTED TO FIND OUT IF IT WAS THE LEAD OR EXTENSION THAT WAS THE ISSUE. WHEN IT WAS DETERMINED TO BE THE LEAD, THE SURGEON DECIDED TO WAIT TO INFORM THE PATIENT BEFORE TAKING ACTION. THE PATIENT WAS NOT SCHEDULED FOR A REPLACEMENT. THE PATIENT WAS DOING FINE, BUT WAS NOT RECEIVING THERAPY ON ONE SIDE DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590231 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention