BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1872588 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07869
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    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 THAT STIMULATION WAS TURNING OFF ON ITS OWN. THE DEVICE WAS INTERROGATED WITH THE PHYSICIAN PROGRAMMER, WHICH INDICATED THERE WAS A POWER ON RESET (POR). THE PT'S STATUS WAS "GOOD." 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., JUNCOS 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| LEAD: MODEL 3887, LOT# *UK6089478| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT008669P| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF017143N