BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1890973 · Received October 29, 2010

    Report

    Report Number
    3004209178-2010-08635
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 4, 2010
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2010, THAT THE PT WAS NOT ABLE TO HEAR THE FREQUENCY OF THE BEEPS MADE BY THE PT'S PROGRAMMER. IT WAS LATER REPORTED THAT THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION DURING DEVICE STIMULATION. THE PT ALSO FELT STIMULATION IN THE WRONG LOCATION: FROM THE ARMS DOWN TO THE BOTTOM OF BOTH FEET, AND IN THE RIBS. IT WAS STATED THAT THE SYMPTOMS BEGAN FOLLOWING A REPROGRAMMING PERFORMED ON (B)(6) 2010. THE PT FURTHER STATED THAT MOVING THE HEAD ALSO CAUSED AN UNCOMFORTABLE CHANGE IN STIMULATION. THE PT WAS TO RETURN TO THE PHYSICIAN FOR "MORE TROUBLESHOOTING" LATER IN THE WEEK OF (B)(6) 2010. NO FURTHER DETAILS OR PT OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED, BUT NOT REC'D AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 60 YR IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3986A, LOT# N091957| PROGRAMMER: MODEL 37743, LOT# NKE148979N