BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO RECHARGEABLE SYSTEM

    MDR report key: 6137994 · Received December 1, 2016

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    Report

    Report Number
    3005025697-2016-00012
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 2, 2016
    Report Date
    January 18, 2017
    Manufacturer
    ENTEROMEDICS, INC.
    Product Code
    PIM
    UDI-DI
    00857334004286
    PMA / PMN Number
    P130019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED; NOT RETURNED.

    Description of Event or Problem · 1

    (B)(6) SUBJECT PARTICIPATING IN (B)(6) WAS IMPLANTED WITH THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2011. DURING A CLINIC VISIT ON (B)(6) 2016, IT WAS DETERMINED THAT A SHORT CIRCUIT OF THE ANTERIOR LEAD HAD BEEN EXPERIENCED ON (B)(6) 2016 AND AN ANTERIOR LEAD OPEN CIRCUIT WAS EXPERIENCED ON (B)(6) 2016. THIS SUBJECT FIRST REPORTED A FLASHING RED LIGHT ON THE MOBILE CHARGER DURING THE CLINIC VISIT ON (B)(6) 2016. DURING THIS VISIT, ALARMS WERE NOTED FOR LOW RNR BATTERY, THE ANTERIOR TIP TO RING SHORT CIRCUIT, AND THE ANTERIOR LEAD OPEN CIRCUIT. THERAPY WAS RE-STARTED AT THIS VISIT, AND ALARMS WERE CLEARED. RED LIGHT WAS REPORTED BY SUBJECT TO HAVE RETURNED ON (B)(6) 2016. DURING AN ADDITIONAL CLINIC VISIT ON (B)(6) 2016, ALARM CODE 3 (IMPEDANCE HIGH) WAS ENCOUNTERED. DIAGNOSTIC EVALUATION REPORTED BY THE SITE INCLUDED ANOTHER ANTERIOR LEAD TIP TO RING OPEN CIRCUIT ON (B)(6) 2016. UPDATE: DEVICE WAS EXPLANTED ON (B)(6) 2016. EXTENSIVE ADHESIONS WERE NOTED DURING THE EXPLANT. THE ENTIRE MAESTRO RECHARGEABLE SYSTEM WAS REMOVED.

    Description of Event or Problem · 1

    (B)(6) SUBJECT PARTICIPATING IN THE (B)(6) CLINICAL TRIAL WAS IMPLANTED WITH THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2011. DURING A CLINIC VISIT ON (B)(6) 2016, IT WAS DETERMINED THAT A SHORT CIRCUIT OF THE ANTERIOR LEAD HAD BEEN EXPERIENCED ON (B)(6) 2016 AND AN ANTERIOR LEAD OPEN CIRCUIT WAS EXPERIENCED ON (B)(6) 2016. THIS SUBJECT FIRST REPORTED A FLASHING RED LIGHT ON THE MOBILE CHARGER DURING THE CLINIC VISIT ON (B)(6) 2016. DURING THIS VISIT, ALARMS WERE NOTED FOR LOW RNR BATTERY, THE ANTERIOR TIP TO RING SHORT CIRCUIT, AND THE ANTERIOR LEAD OPEN CIRCUIT. THERAPY WAS RE-STARTED AT THIS VISIT, AND ALARMS WERE CLEARED. RED LIGHT WAS REPORTED BY SUBJECT TO HAVE RETURNED ON (B)(6) 2016. DURING AN ADDITIONAL CLINIC VISIT ON (B)(6) 2016, ALARM CODE 3 (IMPEDANCE HIGH) WAS ENCOUNTERED. DIAGNOSTIC EVALUATION REPORTED BY THE SITE INCLUDED ANOTHER ANTERIOR LEAD TIP TO RING OPEN CIRCUIT ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789090 MAESTRO RECHARGEABLE SYSTEM ANTERIOR LEAD PIM ENTEROMEDICS, INC. 2200A-47E C4-07861 00857334004286

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R IBUPROFEN 2 TABS PRN| PARACETAMOL 1000 MG PRN