BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2120014 · Received June 8, 2011

    Report

    Report Number
    3004209178-2011-04148
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTABLE NEUROSTIMULATOR AND LEAD HAVE BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT'S IMPLANTABLE NEUROSTIMULATOR SYSTEM WAS EXPLANTED DUE TO INFECTION. A CULTURE WAS SENT BUT THE ORGANISM HAD NOT YET BEEN IDENTIFIED. THE PT WAS NOT INJURED AND RECOVERED WITHOUT SEQUELA. A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE159686N| LEAD: MODEL 39565-65, LOT# V574039024| IMPLANTED: