BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO RECHARGEABLE SYSTEM

    MDR report key: 7795492 · Received August 17, 2018

    Report

    Report Number
    3005025697-2018-00008
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    April 10, 2018
    Report Date
    August 17, 2018
    Manufacturer
    RESHAPE LIFESCIENCES
    Product Code
    PIM
    UDI-DI
    00857334004262
    PMA / PMN Number
    P130019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS NOT ORIGINALLY REPORTED. AFTER ENGINEERING REVIEWED THE CP LOG DATA, IT WAS DETERMINED THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS LIKELY A DAMAGED ANTERIOR LEAD.

    Description of Event or Problem · 1

    PATIENT SUBJECT (B)(6) AT (B)(6) WHO WAS ORIGINALLY AN EMPOWER PATIENT AND HAS CONVERTED TO THE RECHARGEABLE SYSTEM. THE PATIENT WAS EXPERIENCING A FLASHING RED LIGHT ON THEIR MC. RESHAPE'S FIELD SPECIALIST MET THE PATIENT ON (B)(4) 2018. WHEN CONNECTED TO THE CP, ERROR CODES #25 AND #4 WERE DISPLAYED AND CLEARED. THE ON DEMAND IMPEDANCES WERE AS FOLLOWS: 954, 1198, 795, AND 804, 735, 6548. THE THERAPY WAS RESTARTED. A LIVE TEST WAS PERFORMED AND THE PATIENT WAS SENT HOME RECEIVING THERAPY. ON MAY 18, 2018, RESHAPE RECEIVED ADDITIONAL INFORMATION WHEN THE FIELD SPECIALIST VISITED THE SITE. AFTER REVIEWING THE LOGS, THE PATIENT RECEIVED THERAPY FOR 13 DAYS BEFORE A LOW IMPEDANCE ALARM WAS TRIGGERED. THE CP CLEARED THE ALARMS AND ON DEMAND IMPEDANCE MEASUREMENTS WERE PERFORMED AS FOLLOWED: 960, 1211, 781 AND 967, 1241, 781. ANOTHER LIVE TEST WAS PERFORMED AND THE PATIENT WAS SENT HOME RECEIVING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634930 MAESTRO RECHARGEABLE SYSTEM RECHARGEABLE NEUROREGULATOR PIM RESHAPE LIFESCIENCES 2002 00857334004262

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention