BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2191013 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-05568
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIAL IMPLANT SURGERY, THE HEALTH CARE PROVIDER INSERTED THE LEAD INTO THE PATIENT AND THEN PULLED IT OUT. THE HEALTH CARE PROFESSIONAL NOTED THAT THE END OF THE LEAD WAS "BROKEN." ANOTHER LEAD WAS USED AND THE SURGERY WAS COMPLETED WITHOUT INCIDENT. THERE WERE NO PATIENT CONSEQUENCES AS A RESULT OF THE LEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION 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 54 YR IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA154045N| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V743853005| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE167730N| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V477971034| EXPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT# N289245| EXPLANTED: