BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2211882 · Received August 10, 2011

    Report

    Report Number
    3004209178-2011-06217
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TELEMETRY ISSUES WERE REPORTED. THE ANTENNA-LOCATE FEATURE WAS UTILIZED AND RESULTED IN THE RECHARGER DISPLAYING IN A POWER-ON-RESET (POR) MESSAGE, FOLLOWED BY THE NORMAL RECHARGING. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR IMPLANTED:| LEAD: MODEL 3487A, LOT# J0406096V| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU044873V| LEAD: MODEL 3487A, LOT# J0406477V| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT039560P| EXTENSION: MODEL 7482, LOT# NHU044874V| IMPLANTED:| EXPLANTED: