BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1944295 · Received December 6, 2010

    Report

    Report Number
    6000032-2010-10219
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MEL REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    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

    THE PT HAD NO STIMULATION SENSATION ON THE LEFT SIDE. IMPEDANCE READINGS WERE >4000 OHMS ON SOME OF THE BIPOLAR PAIRS. THE LOW BATTERY MESSAGE APPEARED DURING THE PROGRAMMING SESSION. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MDT PUERTO RICO OPERATIONS CO, MEL REL 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR PROGRAMMER: MODEL 7435, LOT# NFT042348P| LEAD: MODEL 3887, LOT# J0421723V| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU026429V| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU050826V| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3887, LOT# J0417886V