BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1890196 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-08293
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 20, 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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DECREASED THE STIMULATION TO 1.6V USING THE DECREASE BUTTON. THE PT EXPERIENCED A SHOCK AND TURNED OFF THE STIMULATION, WHICH WAS AT 5.0V. THE PT WAS "SURE" THAT THE DECREASE BUTTON WAS USED BUT "WAS NEW AT THIS TIME, SO [SHE] MAY HAVE MADE A MISTAKE." ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 57 YR LEAD: MODEL 39565-65, LOT #: N210290001| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT #: NKE138992N