BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2043585 · Received March 28, 2011

    Report

    Report Number
    3004209178-2011-02342
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    June 14, 2007
    Report Date
    March 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS STATED THAT THE RIGHT-SIDE LEAD MIGRATED. INTERVENTION AND OUTCOME ARE UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR IMPLANTED:| PROGRAMMER: MODEL 37742, LOT # NJD045732N| LEAD: MODEL 3778, LOT # V028772011| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT # V040639028| EXPLANTED: