BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2101934 · Received May 18, 2011

    Report

    Report Number
    3004209178-2011-03627
    Event Type
    Injury
    Date Received
    May 18, 2011
    Report Date
    April 18, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S DEVICE DEPLETED IN 6 WEEKS. THE DEVICE HAD FAIRLY NORMAL PARAMETERS OF USE. HIGH IMPEDANCES WERE INITIALLY REPORTED. THE DEVICE HAD THE ERI MESSAGE. FURTHER INFO INCLUDED LOW OUT OF RANGE IMPEDANCE VALUES. THERE WERE NO FALLS OR INCIDENTS. THE PT PLANNED ON HAVING THE DEVICE REPLACED, BUT NOTHING WAS SCHEDULED AS OF THE DATE OF THIS REPORT.

    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 NA Female Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V523368020.| LEAD: MODEL 3778, LOT# V523368021.| PROGRAMMER: MODEL 37743, LOT# NKE163346N.| EXPLANTED:| LEAD: MODEL 3778, LOT# V523368020| IMPLANTED:| LEAD: MODEL 3778, LOT# V523368021| PROGRAMMER: MODEL 37743, LOT# NKE163346N| EXPLANTED:| IMPLANTED: