BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2531928 · Received April 12, 2012

    Report

    Report Number
    3004209178-2012-02331
    Event Type
    Malfunction
    Date Received
    April 12, 2012
    Report Date
    June 1, 2012
    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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEUROSTIMULATOR MODEL # 37612, SERIAL # (B)(4), IMPLANTED (B)(6) 2012-02, EXPLANTED UNKNOWN; LEAD MODEL # UNKNOWN, LOT # UNKNOWN, IMPLANTED (B)(6) 2007, EXPLANTED UNKNOWN; RECHARGER MODEL # 37651, LOT # NKA153142N; PROGRAMMER MODEL # 37642, LOT # NJZ118557N; ADAPTOR MODEL # 64001, LOT # N301004, IMPLANTED (B)(6) 2012, EXPLANTED UNKNOWN; EXTENSION MODEL # 7482A51, LOT # NHU202083V, IMPLANTED (B)(6) 2009, EXPLANTED UNKNOWN; LEAD MODEL # 3387S-40, LOT # V142617, IMPLANTED (B)(6) 2008, EXPLANTED UNKNOWN; EXTENSION MODEL # 7482A51, LOT # NHU181075V, IMPLANTED (B)(6) 2008, EXPLANTED UNKNOWN; ADAPTOR MODEL # 64001, LOT # N301593, IMPLANTED (B)(6) 2012, EXPLANTED UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN, HOWEVER, THE PHYSICIAN BELIEVED IT "MAY HAVE BEEN PATIENT ERROR IN READING THE PATIENT PROGRAMMER." THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS FOUND THROUGH INTERROGATION OF THE IMPLANTABLE NEUROSTIMULATOR. THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THIS EVENT. THE PATIENT OUTCOME WAS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S INS WAS STAYING CHARGED AT 100% AND NOT DEPLETING NORMALLY AS IT HAD IN THE PAST. THE PATIENT TYPICALLY CHARGED BOTH OF HER INS'S DAILY. ONE OF THE DEVICES WAS SHOWING 100% CHARGED WHEN SHE STARTED THE CHARGE SESSION. AT 8840 RECHARGE STATS: 3/25, 0.7 HRS, 100%, 3/25, 0.1, 100%; 3/24 0.1, 100%; 3/24, 0.2, 100%; 3/24 0.0, 100%. INS USE FOR THIS SIDE IS 100% SO STIM APPEARED TO BE ON THE WHOLE TIME. ELECTRODE IMPEDANCES ALL NORMAL RANGE WITH THERAPY IMPED OF 724 OHMS (4.5V, 120US, 130HZ, C+, 1-2-). THE PATIENT HAD BEEN GETTING RADIATION TREATMENT FOR 6 WEEKS TO THE SIDE OF HER BODY WHERE INS WASN'T DEPLETING AS EXPECTED. THE PATIENT'S STIM THERAPY FOR THAT SIDE WASN'T AS GOOD DURING THE TIME THAT INS DIDN'T APPEAR TO BE DISCHARGING. TODAY, HOWEVER, THE THERAPY WAS GOOD AND FEELING LIKE IT ALWAYS HAD. THEY PLANNED TO MONITOR RECHARGE STATS AND STIM THERAPY GOING FORWARD. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2012-02328.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1