BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4570163 · Received March 4, 2015

    Report

    Report Number
    3004209178-2015-04120
    Event Type
    Malfunction
    Date Received
    March 4, 2015
    Report Date
    February 12, 2015
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# L84568, IMPLANTED: 2000-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: 2000-(B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: 2000-(B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-4,0 LOT# L84569, IMPLANTED: 2000-(B)(6), PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LASER PROCEDURE OVER THE IMPLANT ON THE DAY PRIOR TO THE DATE OF THIS REPORT TO REMOVE A SCAR THAT WAS OVER THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANT SITE. SINCE THE DAY PRIOR TO THE DATE OF THIS REPORT THE PATIENT¿S VOICE HAD GOTTEN SOFTER, HIS BALANCE WAS OFF AND WALKING WAS DIFFICULT. IT WAS NOTED THAT MOST OF THE SYMPTOMS WERE FROM THE DATE OF THIS REPORT BUT IT HAD STARTED ON THE DAY PRIOR. THE PATIENT HADN¿T HAD BATTERIES FOR THE PROGRAMMER TO CHECK THE IMPLANT. THE PATIENT HAD AN APPOINTMENT WITH HIS NEUROLOGIST ON THE DAY FOLLOWING THE DATE OF THIS REPORT. NO INTERVENTION OR OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151255 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR