BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2019033 · Received February 7, 2011

    Report

    Report Number
    3004209178-2011-00926
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Report Date
    January 19, 2011
    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).

    Description of Event or Problem · 1

    THE PT EXPERIENCED INTERMITTENT STIMULATION. THE PREVIOUS INS CAUSED INTERMITTENT STIMULATION WHEN IT REACHED A LOW STATUS SO IT WAS THOUGHT THAT THE CURRENT INS WAS REACHING EOL. HOWEVER, THE BATTERY MEASUREMENT WITH THE 8840 INDICATED THE BATTERY STATUS WAS "OK". HE WAS AT THE CLINIC IN GOOD CONDITION. ADD'L INFO HAS BEEN REQUESTED.

    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 37 YR EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7425,| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU024243V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3587A, LOT# LB5962| LOT# NAT145992H| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT060687P| EXPLANTED:| UNK CONVERSION TYPE: MODEL 3550-09, LOT# LC3120