BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTOR ULTRA

    MDR report key: 1840773 · Received September 17, 2010

    Report

    Report Number
    3004209178-2010-07084
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADDITIONAL INFORMATION IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    DURING IMPLANT IT WAS NOT POSSIBLE TO ADVANCE THE STYLET PAST THE #7 CONTACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR IMPLANTED:| LEAD: MODEL #3777, LOT #V483812011| LEAD: MODEL #3777, LOT #V378914021| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL #3777, LOT #UNK| STYLET: LOT #UNK,| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL #37752, LOT #NKA142554N| IMPLANTED:| IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL #3550-39, LOT #N254683| PROGRAMMER: MODEL #37743, LOT #NKE153133N