BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 1000151 · Received February 19, 2008

    Report

    Report Number
    3004209178-2008-00790
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    March 20, 2007
    Report Date
    January 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT INS SITE; THE AREA OVERLYING THE GENERATOR HAD BEEN PAINFUL WITH SYMPTOMS OF FLUCTUANT, WARM AND ERYTHEMATOUS SKIN NOTED. NO FEVER OR CHILLS WERE REPORTED. THE PULSE GENERATOR WAS SUBSEQUENTLY REPLACED (EXACT DATE WAS NOT PROVIDED); THE PATIENT HAD RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention IMPLANTED:| EXPLANTED:| LEAD MODEL 3777 LOT# V003918| EXPLANTED:| EXTENSION MODEL 37082 LOT# NKB005704N| LEAD MODEL 3999 LOT# V015088| EXPLANTED:| IMPLANTED:| IMPLANTED: