BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2994388 · Received March 8, 2013

    Report

    Report Number
    3004209178-2013-03486
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    November 28, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_UNKNOWN_LEAD LOT#, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PREVIOUSLY REPORTED CONCLUSION CODES NO LONGER APPLY TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A REVISION SURGERY FOR THEIR LEFT LEAD IN (B)(6) 2013. SIGNIFICANT REPROGRAMMING WAS DONE PRIOR TO THE REVISION BUT IT WAS REPORTED, THE HEALTHCARE PROVIDER CONSIDERED THE LEAD TO BE "POORLY PLACED." IT WAS ALSO REPORTED, THE LEFT LEAD WAS REPLACED BECAUSE THE HEALTHCARE PROVIDER THOUGHT THE PLACEMENT OF THE LEAD WAS NOT PROVIDING THE PATIENT EFFECTIVE THERAPY. AFTER THE REPLACEMENT, IT WAS REPORTED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S LEFT LEAD WAS NOT REPLACED AND THE PATIENT'S RIGHT LEAD WAS REPLACED AS REPORTED IN MFR. REPORT # 3004209178-2013-03488 REGARDING THE PATIENT'S RIGHT DEVICE SYSTEM. IT WAS REPORTED THAT THE PATIENT WAS NOW RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98801 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention