BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY PLUS+

    MDR report key: 1872416 · Received October 11, 2010

    Report

    Report Number
    3004209178-2010-07809
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 18, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    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). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PT WAS PARTICIPATING IN SOME ACTIVITY OR EXERCISE AND, WHILE "BENDING OVER WITH SOME TWISTING MOTION" THE PT "THOUGH HE HEARD A POPPING SOUND," THEN LOST STIMULATION FROM HIS DEVICE. IT WAS STATED THAT IMPEDANCES ON THE DEVICE WERE >4000 OHMS ON ALL OF THE BIPOLAR PAIRS. 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 PLUS+ LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7479 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR EXTENSION: MODEL 7495-25, LOT# NAF007209N| EXPLANTED:| LEAD: MODEL 3587A, LOT# L84875| EXPLANTED:| IMPLANTED:| IMPLANTED: