BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2190401 · Received July 25, 2011

    Report

    Report Number
    3004209178-2011-05775
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEIZURES. THE PATIENT HAD A TRIAL PROCEDURE THAT STARTED ON (B)(6) 2011 AND (B)(6) LATER HAD 4 SEIZURES. THE PATIENT HAD A PERMANENT IMPLANT PLACED, BUT HAD THE ENTIRE SYSTEM REMOVED ON (B)(6) 2011. ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V664925| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB007060V| LEAD: MODEL 3888, LOT# V664925| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE162433N| LEAD: MODEL 3998, LOT# V664926| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB005848V| IMPLANTED:| EXPLANTED: