BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3759509 · Received April 18, 2014

    Report

    Report Number
    3004209178-2014-07525
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 31, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V022878, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7436, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3389S-40, LOT# V939081, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE REPLACEMENT THE PATIENT HAD EXPERIENCED SYMPTOMS THAT SHE NEVER HAD BEFORE. WHENEVER THE PATIENT WALKED SHE FELT LIGHT-HEADED. THE PATIENT FELT A LOT OF PRESSURE IN HER HEAD ¿LIKE A BALLOON.¿ WHEN THE PATIENT STOOD UP SHE HAD FLEETING BLURRED VISION. THE PATIENT ALSO HAD A LOT OF WEAKNESS AND WAS DEBILITATED. THE PATIENT FELT SHE HAD TREMORS, THOUGH THE REPORTER COULD NOT SEE THEM. THE PATIENT ALSO FELT TINGLING AND SHOCKING IN HER HEAD. THE PATIENT HAD NO FALLS OR TRAUMA. THE PATIENT SAW HER DOCTOR AND HE ADJUSTED HER SETTINGS AND PROVIDED A PATIENT PROGRAMMER FOR AT HOME ADJUSTMENTS. THE DOCTOR TOLD THE PATIENT AND REPORTER THAT HE ¿CHECKED THE DEVICE AND THE DEVICE WAS WORKING AS IT SHOULD BE.¿ THE PATIENT TURNED THE THERAPY OFF FOR THREE DAYS AFTER HER VISIT ON (B)(6) 2014 AND THE TINGLING AND SHOCKING WENT AWAY. THE DOCTOR THEN TOLD THE PATIENT THAT THE TINGLING AND SHOCKING WAS FROM THE DEVICE. THE PATIENT WAS VERY HAPPY WITH THE THERAPY PREVIOUSLY AND WAS FULLY FUNCTIONAL PRIOR TO REPLACEMENT. HOWEVER, WITHOUT THE THERAPY THE PATIENT HAD A LOT OF TREMORS. THE REPORTER STATED THAT SINCE THE VISIT SHE HELPED THE PATIENT LOWER ONE SIDE FROM 3.5 VOLTS TO 3.1 VOLTS. BRINGING DOWN THE VOLTAGE HAD HELPED SOMEWHAT WITH THE SYMPTOMS. HOWEVER, THE PATIENT CONTACTED THE REPORTER ON THE DAY OF THE REPORT AND STATED THAT SHE FELT BAD ENOUGH THAT SHE WAS NOT SURE WHETHER OR NOT TO GO TO THE EMERGENCY ROOM (ER). LATER THAT DAY IT WAS REPORTED THAT THE PATIENT THOUGHT SHE WAS EXPERIENCING THE SAME SYMPTOMS AS WHEN THE FIRST IMPLANTABLE NEUROSTIMULATOR (INS) ¿WENT BAD.¿ SOME DAYS THE PATIENT STARTED OFF FEELING GOOD, BUT THEN GOT UP AND PERFORMED NORMAL ACTIVITIES AND THE GOOD FEELING WAS GONE. THE PATIENT WAS NAUSEATED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236925 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR