BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4418548 · Received January 14, 2015

    Report

    Report Number
    3004209178-2015-00699
    Event Type
    Malfunction
    Date Received
    January 14, 2015
    Report Date
    December 23, 2014
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387-40, LOT# J0108063V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# J0108117V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THERE WAS LOW THERAPY/UNIPOLAR IMPEDANCES. THIS HAD BEEN AN ISSUE SINCE IMPLANT ON (B)(6) 2014. THE IMPEDANCES FROM (B)(6) 2015 WERE AS FOLLOWS: C0=274 OHMS, C1=211 OHMS, C2=210 OHMS, C3=213 OHMS AND THERAPY=208 OHMS AT 14.975 MA. THE IMPEDANCE AT THE TIME OF REPLACEMENT WAS C0=296 OHMS, C1=328 OHMS, C2=369 OHMS, C3=345 OHMS AND THERAPY=286 OHMS. THERE WERE NO ADVERSE EVENTS OR POOR THERAPY, JUST CONCERNS ABOUT THE IMPEDANCE. IT WAS NOTED THAT A REVISION OF THE EXTENSION MAY OCCUR WHEN THE CURRENT IMPLANTABLE NEUROSTIMULATOR (INS) GETS REPLACED. IT WAS FURTHER REPORTED ON (B)(6) 2015 THAT AT THE LAST APPOINTMENT THE BATTERY VOLTAGE WAS 2.6 VOLTS AND THE BATTERY VOLTAGE ON (B)(6) 2015 WAS 2.74 VOLTS. THE THERAPY IMPEDANCE ON (B)(6) 2015 WAS 182 OHMS. THE OTHER RESULTS FROM THIS IMPEDANCE TEST WERE AS FOLLOWS: C0=187 OHMS, C1=213 OHMS, C2=186 OHMS, C3=182 OHMS, 01=270 OHMS, 02=113 OHMS, 03=98 OHMS, 12=262 OHMS, 13=257 OHMS, AND 23=30 OHMS. IT WAS 300 OHMS AT THE LAST BATTERY CHANGE AND 800-1000 OHMS AT AN APPOINTMENT BEFORE THE REPLACEMENT. NO SYMPTOMS WERE REPORTED. THE INDICATION-FOR-USE (IFU) WAS PARKINSON'S DUAL AND MOVEMENT DISORDERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT BATTERY THERAPY IMPEDANCE MEASUREMENTS WERE ON (B)(6) 2014 ¿ 211 OHMS 14.807 MA, (B)(6) 2014 ¿ 250 OHMS 12.788 MA, AND (B)(6) 2014 316 OHMS 10.432 MA. CURRENT IMPEDANCE MEASUREMENTS WERE NORMAL. FOLLOWING BATTERY REPLACEMENT IN (B)(6) PRIOR TO THE DATE OF THIS REPORT THE PATIENT HAD SOME SWELLING AROUND THE RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO A MEDICATION THAT THE PATIENT WAS ON. THE PATIENT HAD A FALL IN OCTOBER PRIOR TO THE DATE OF THIS REPORT. THE PATIENT WAS CLINICALLY DOING FINE AND HAD GOOD CONTROL OF THEIR GAIT AND FACIAL DYSTONIA. THE MANUFACTURE OBTAINED IMPEDANCE VALUES FROM THE CLINIC AND PATIENT¿S IMPEDANCES WERE C/0-661, C/1-591, C/2-567, C/3-631, 0/1-531, 0/2-685, 1/2-451, 1/3-675 AND 2/3-507. THE PATIENT WAS GETTING THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE IMPEDANCE ISSUE WERE DUE TO PRE-EXISTING ISSUES THAT WERE REFERENCED IN THE NEUROLOGIST¿S NOTES. THEY WERE UNSURE IF IT WAS DEVICE RELATED AND NO LEAD FRACTURES WERE NOTED. NO TROUBLESHOOTING OR INTERVENTIONS WERE TAKEN AND THE PATIENT WAS RECEIVING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32106 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR