BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1463161 · Received July 13, 2009

    Report

    Report Number
    3004209178-2009-04785
    Event Type
    Malfunction
    Date Received
    July 13, 2009
    Date of Event
    June 16, 2009
    Report Date
    June 16, 2009
    Manufacturer
    MPROC, JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    96009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT SURGERY, HIGH IMPEDANCES WERE REPORTED. ELECTRODE SHOWS 'OUT OF RANGE' BOX ON THE 8840 AT 3V/80PW/100HZ ON THE RIGHT SIDE WAS ONLY C11 AT 2164. READINGS ON THE LEFT SIDE AT THE SAME SETTINGS C0: 3161, C1: 5289, C2: 11739, C3: 2354, 01: 7155, 02: 1582003: 5432, 12: 14372, 13: 7288, 23: 13675. FIVE MINUTES LATER, LEFT SIDE IMPEDANCES WERE TESTED AGAIN AND NOTED: C0: 12688 OHMS, C1: 7288 OHMS, C2: 35409 OHMS, C3: 2778 OHMS, 01: 15431 OHMS, 02:>40,000 OHMS, 03: 15431 OHMS, 12: 3297 OHMS, 13: 9920 OHMS, 23: 36223 OHMS. THE PT WAS SEEN AGAIN THE NEXT DAY ((B) (6) 2009) AND IMPEDANCES WERE CHECKED AGAIN. THE IMPEDANCE MEASUREMENTS ON THE RIGHT SIDE WERE ALL NORMAL EXCEPT C11 AT 2,369. THE LEFT SIDE IMPEDANCES MEASURED C & 0 15,584; C & 1 8,518; C & 2 36,223; C & 3 3,218; 0 & 1 18,308; 0 & 2 >40,000; 0 & 3 18,857; 1 & 2 30,297; 1 & 3 11,115; 2 & 3 37,076. IT WAS FELT THERE WAS LIKELY AN OPEN CIRCUIT WITH THE #2 CONTACT ON THE LEFT SIDE AND THAT THE OTHER CONTACTS WERE OK. THE PT WAS SEEN AGAIN APPROX TWO WEEKS LATER ((B) (6) 2009). LEFT SIDE IMPEDANCES WERE THE SAME AS THOSE MEASURED ON (B) (6) 2009. FURTHER HIGH IMPEDANCES WERE SEEN ON THE RIGHT SIDE: C & 11 2369, 8 & 9 2423, 8 & 10 2651, 8 & 11 3244, 9 & 10 3085, 9 & 11 3908, AND 10 & 11 3595. THE PT WAS BEING SEEN FOR PROGRAMMING ON (B) (6) 2009. NO PT SYMPTOMS OR OUTCOME WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MPROC, JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| PROGRAMMER: MODEL 8840, LOT# UNK| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| EXPLANTED:| IMPLANTED:| LEAD: MODEL UNK, LOT# UNK| LEAD: MODEL UNK, LOT# UNK| IMPLANTED: