BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5791704 · Received July 13, 2016

    Report

    Report Number
    3004209178-2016-14144
    Event Type
    Injury
    Date Received
    July 13, 2016
    Date of Event
    June 14, 2016
    Report Date
    July 13, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V616865, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V241399, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP)REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS ALSO REPORTED THAT THE PATIENT'S SKIN WAS THIN OVER THE LEAD LOCATION SO A REVISION WAS PERFORMED ON (B)(6) 2016 TO GRAFT SKIN OVER THE LEAD WIRES. THE HCP NOTED THAT THE REVISION WAS NOT AN IMMEDIATE ISSUE AND WAS PERFORMED AS A PRE-EMPTIVE MEASURE. IT IS UNKNOWN WHEN THE ISSUES BEGAN OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445024 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention