BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2000310 · Received February 17, 2011

    Report

    Report Number
    3004209178-2011-01187
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    November 1, 2009
    Report Date
    February 1, 2011
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT HAD A REVISION DUE TO THE MIGRATION OF THE LEAD TIP. THE INS WAS ALSO REPLACED DUE TO BATTERY END OF LIFE. THIS WAS REPORTED AS A NON SERIOUS INJURY/ILLNESS. THE PT DEVELOPED AN INFECTION AFTER THIS REVISION AND THE SYSTEM WAS EXPLANTED. PLEASE SEE MFR REPORT # 3004209178200909678 FOR DETAILS REGARDING THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA125112N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT # V148668033| PROGRAMMER: MODEL 37743, LOT# NKE124326N| EXTENSION: MODEL 37081, LOT# NJB052385V| IMPLANTED: