BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1902216 · Received November 15, 2010

    Report

    Report Number
    3004209178-2010-09555
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    August 12, 2008
    Report Date
    November 2, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS 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). THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S DEVICE WAS REPLACED DUE TO AN INFECTION AT THE POCKET SITE. THE PT REPORTEDLY EXPERIENCED PAIN AT THE DEVICE SITE, THE DEVICE WAS EXPLANTED ON (B)(6) 2008 AND REPLACED ON (B)(6) 2008, AND THE PT RECOVERED WITHOUT SEQUELA.

    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 48 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE105956N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V095073008| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V073136030| EXPLANTED: