BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3813141 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09036
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 24, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V287456, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# VA07HHJ, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT PROGRAMMER DISPLAYED A ¿CALL YOUR DOCTOR¿ ICON AND A POWER ON RESET (POR) CONDITION. THE PATIENT DESCRIBED THE WARNING POR SCREEN THAT NEEDED TO BE RESET BY A CLINICIAN PROGRAMMER. THE PATIENT ALSO NOTICED SOME CHANGE IN HER THERAPY THE DAY PRIOR TO THE REPORT, BUT SHE WAS ABLE TO RECHARGE HER IMPLANTABLE NEUROSTIMULATOR (INS). ON THE DAY OF THE REPORT THE PATIENT¿S TREMORS WERE VERY BAD AND SHE COULD NOT CONNECT TO HER INS. THE PATIENT¿S SPOUSE NOTED THAT THE PATIENT WENT TO THE DENTIST THREE DAYS PRIOR TO THE REPORT AND THE DENTIST USED A DRILL. THE PATIENT HAD CALLED HER DOCTOR¿S OFFICE AND WAS WAITING FOR A CALL BACK. LATER THAT DAY IT WAS REPORTED THAT THE POR HAD BEEN SHOWING ON THE RECHARGER SINCE THE NIGHT PRIOR TO THE REPORT. THE PATIENT WAS TREMBLING AND HER TREMORS HAD RETURNED. THE REPORTER STATED THAT THE PATIENT WAS ¿VISUALLY RATTLED BECAUSE OF THE TREMORS.¿ THE REPORTER NOTED THAT THE TREMORS BEGAN THE NIGHT PRIOR TO THE REPORT. FOUR DAYS LATER IT WAS REPORTED THAT THE PATIENT HAD A 0X400 POR CODE. THE REPORTER CLEARED THE POR AND THAT RESOLVED THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S DOCTOR DID NOT KNOW WHAT WAS WRONG. THE PATIENT LISTED AN APPOINTMENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291276 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1