BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3672384 · Received March 11, 2014

    Report

    Report Number
    3004209178-2014-04213
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Report Date
    February 17, 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
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V023690, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V068863, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A METALLIC TASTE IN THEIR MOUTH ALONG WITH SHOCKING ONLY WHEN THEY RECHARGED. IT WAS STATED THEIR TREMOR CONTROL HAD NOT BEEN AS GOOD SINCE THEY RECEIVED THEIR NEW IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THE METALLIC TASTE WAS LIKE ¿BITING COPPER¿ SPECIFICALLY WHEN THEY WOULD RECHARGE. IT WAS STATED IT WOULD OCCUR THE ENTIRE TIME THEY WOULD CHARGE, REGARDLESS OF BATTERY STRENGTH. IT WAS STATED IT BECAME WORSE AND NOT ONLY WAS IT A METALLIC TASTE BUT ALSO A SHOCK-LIKE FEELING IN THEIR LOWER JAW. IT WAS NOTED THEY ALSO HAD A HEADACHE AND NAUSEA. IT WAS FURTHER REPORTED THE PATIENT WAS SEEN ON THE DAY OF REPORT AND THEY STILL HAD THE METALLIC TASTE IN THEIR MOUTH WITH A HEADACHE AND NAUSEA. IT WAS NOTED THEY WOULD TRY TO RECHARGE WITH THE BATTERY OFF. ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS UNSURE WHAT THE CAUSE OF THE EVENT WAS. IT WAS STATED THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. IT WAS NOTED REPROGRAMMING WAS PERFORMED 6 DAYS PRIOR TO REPORT. IT WAS STATED THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145722 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR