BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2101722 · Received May 11, 2011

    Report

    Report Number
    3004209178-2011-03425
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 6, 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
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THAT WHILE THE STIMULATION IS TURNED OFF, THE PATIENT SHOCKS OTHER PEOPLE. PATIENT EXPERIENCED THIS WHILE WALKING AT THE STORE IN PHARMACY AND SHE WOULD PICK UP PRESCRIPTIONS. REPORTS IT HAPPENED IN THE COLDER WEATHER. PATIENT ALSO EXPERIENCED DIFFICULTY ADJUSTING STIMULATION. SHE WAS ONLY ABLE TO ADJUST ON THE RIGHT SIDE OF HER BODY. THE PHYSICIAN HAD DONE AN X-RAY SUSPECTING THE LEADS MAY HAVE SHIFTED. PATIENT HAD A FOLLOW UP APPOINTMENT AND WOULD HOPEFULLY GET THE X-RAY RESULTS AT THAT TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    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 57 YR Female Other "SEE H10...."| EXPLANTED.| EXPLANTED.| IMPLANTED.| IMPLANTED.| LEAD: MODEL 3778, LOT# V572265018.| LEAD: MODEL 3778, LOT# V572265019.| PROGRAMMER: MODEL 37743, LOT# NKE158817N.| PROGRAMMER: MODEL 37743, LOT# NKE158817N| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V572265019| EXPLANTED:| LEAD: MODEL 3778, LOT# V572265018