BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2140965 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04644
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION TOOK PLACE ON (B)(6)-2011; TWO MODEL 7489 EXTENSIONS AND A MODEL 3999 LEAD WERE EXPLANTED. THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION 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 MDT PUERTO RICO OPERATIONS CO., JUNCOS 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention EXPLANTED:| LEAD: MODEL 3999, LOT# V028473| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU081529V| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU080956V| IMPLANTED: