BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2000346 · Received February 18, 2011

    Report

    Report Number
    3004209178-2011-01232
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC 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).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A POCKET REVISION DUE TO THE INS HURTING THEIR HIP. THE INS WAS GOING TO BE MOVED TO A DIFFERENT LOCATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention PROGRAMMER: MODEL 37743, LOT# NKE147245N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB064107V| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V269615017| EXPLANTED: