BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1901964 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-09456
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 29, 2010
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT BEGAN EXPERIENCING STIMULATION IN HER CERVICAL AND THORACIC REGIONS. AN X-RAY WAS PERFORMED SHOWING THERE WAS LEAD MIGRATION. THE LEAD WAS SURGICALLY REPOSITIONED ON (B)(6) 2010. NO OUTCOME WAS REPORTED.

    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 68 YR Required Intervention IMPLANTED:| LEAD: MODEL 3778, LOT# V490056032| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V467929004| PROGRAMMER: MODEL 37743, LOT# NKE155115N