BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4446994 · Received January 23, 2015

    Report

    Report Number
    3004209178-2015-01135
    Event Type
    Injury
    Date Received
    January 23, 2015
    Report Date
    January 5, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 64002, LOT# N242111, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER; PRODUCT ID 3389S-40, LOT# V207104, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3389S-40, LOT# V207104, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 7482A66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD SHAKING SYMPTOMS FROM PARKINSON¿S DISEASE WITH THE DEEP BRAIN STIMULATION SYSTEM. THE SHAKING HAD ALWAYS BEEN PRESENT SINCE IMPLANT AND THE THERAPY DID NOT HELP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) SAW THE PATIENT ON THE DAY OF THE REPORT IN THE CLINIC AND DID AN IMPEDANCE CHECK. MULTIPLE COMBINATIONS ON THE LEFT AND RIGHT SIDE WERE GREATER THAN 10,000 OHMS; THE COMBINATION OF 0 AND 1 WAS EVEN GREATER THAN 40,000 OHMS. THE REVISION WAS SCHEDULED FOR (B)(6) 2015. ON THE DAY OF THE REVISION IT WAS REPORTED THAT THE 0 AND 4 ELECTRODES WERE HIGH. THE OTHER VALUES WERE WITHIN NORMAL RANGE, SO THEY WANTED TO REPROGRAM AROUND THE HIGH ELECTRODES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEW RC GENERATOR PLACED ON (B)(6) 2014 HAD NOT BEEN AS ¿EFFECTIVE¿ AS THE PREVIOUS GENERATOR. THE MANUFACTURING REPRESENTATIVE STATED THE PATIENT HAD SEEN AN OOR MESSAGE OF THE PROGRAMMER ABOUT A WEEK AND A HALF PRIOR TO THE CALL. AN IMPEDANCE TEST WAS RUN ON (B)(6) 2015. RESULTS SHOWED THE TOP PORT (LEFT SIDE) HAD NO ISSUES BUT THE BOTTOM PORT (RIGHT SIDE) CONTACT 4 HAD HIGH IMPEDANCE. A SECOND IMPEDANCE TEST WAS RUN ON THE DAY OF THE CALL AND THE VALUES HAD CHANGED. RESULTS SHOWED THE TOP PORT (LEFT SIDE) ALL COMBINATIONS WITH CONTACT 0 OR 1 HAD HIGH IMPEDANCE AND THE BOTTOM PORT (RIGHT SIDE) HAD SAME ISSUE, ALL COMBINATIONS WITH CONTACT 4 WERE HIGH. IT WAS INQUIRED ON HOW THE IMPEDANCES HAD CHANGED AND THE MANUFACTURING REPRESENTATIVE THOUGHT THERE WAS A CONNECTION ISSUE AND THAT AN ADAPTOR WAS USED. THE DOCTOR PROGRAMMED AROUND THE ISSUE CONTACT BUT THE PATIENT WAS NOT DOING WELL. A REVISION WAS SCHEDULED THE WEEK OF (B)(6). NO FALLS OR TRAUMAS WERE REPORTED AND PATIENT OUTCOME IS UNKNOWN. FURTHER FOLLOW-UP HAS BEEN REQUESTED TO OBTAIN THIS INFORMATION AND IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55468 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention