BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2220217 · Received August 16, 2011

    Report

    Report Number
    3004209178-2011-06419
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 21, 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
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A LEAD REVISION PERFORMED SIX WEEKS AGO. NO FURTHER DETAILS OR PT SYMPTOMS WERE REPORTED RELATED TO THE NEED FOR THE REVISION PROCEDURE. THE PT RECOVERED WITHOUT SEQUELA FROM THE PROCEDURE. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    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 48 YR Required Intervention IMPLANTED:| RECHARGER: MODEL 37752, LOT# NKA125919N| PROGRAMMER: MODEL 37743, LOT# NKE141133N| LEAD: MODEL 3888, LOT# L42179| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC009603N