BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1993771 · Received January 13, 2011

    Report

    Report Number
    3004209178-2011-00356
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 30, 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

    THE PT DID NOT HAVE THERAPEUTIC EFFECT AND IT WAS STATED THAT THE DEVICE HAD TURNED OFF. SHE WAS SET FOR A PUMP IMPLANT ON (B)(6) 2011 AND WANTED TO HAVE THE STIMULATOR REPROGRAMMED BEFORE THEN. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    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 IMPLANTED:| LEAD: MODEL 3982, LOT# NBB002663N| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE158952N| EXPLANTED:| ADAPTER: MODEL 74001, LOT# N202184| EXTENSION: MODEL 7496-51, LOT# YR0010235N| EXPLANTED:| IMPLANTED:| IMPLANTED: