BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2081042 · Received April 14, 2011

    Report

    Report Number
    3004209178-2011-02823
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    June 1, 2009
    Report Date
    March 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIOSN 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

    RECEIVED INFORMATION THE PT WAS OCCASIONALLY HEARING A STATIC SOUND IN HIS RIGHT EAR FROM THE MICROWAVE OR THE REFRIGERATOR. THE PT HAS LEADS IMPLANTED IN HIS BACK. ADDITIONAL INFORMATION STATED THE PT WAS SEEN AND LEAD FRACTURES WERE IDENTIFIED. HE WAS IN THE PROCESS OF GETTING AUTHORIZATION FOR REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIOSN CO., JUNCOS 37702 H0231155

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE126937N| IMPLANTED:| LEAD: MODEL 3999, LOT# V027463| EXTENSION: MODEL 37082, LOT# NKB014831N| IMPLANTED: