BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2211098 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06158
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 13, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE NECK AREA AND A "POKING FEELING" WHEN THE NECK WAS MOVED. IT WAS SUGGESTED THAT THIS MAY BE THE TIP OF ONE OF THE LEADS. THE AREA OF THE REPORTED PAIN, HOWEVER, WAS NOT CONSISTENT WITH THE LOCATION OF THE LEAD. REVISION OF LEAD WAS, THUS, RULED OUT. THE PATIENT WAS, ALSO, NOT ABLE TO LIFT THE LEFT ARM ABOVE THE HEAD W/O SEVERE DISCOMFORT IN THE AREA OF THE IMPLANTABLE NEUROSTIMULATOR (BENEATH THE CLAVICAL). THE BATTERY AND LEADS WERE TESTED AND SHOWN TO BE OPERATING PROPERLY, WITH NORMAL IMPEDANCE READINGS. NO FURTHER DIAGNOSTICS WERE TO BE PERFORMED. THE PATIENT DID NOT WANT TO CONSIDER REVISION OF THE DEVICE SITE, BUT DID REQUEST EXPLANTATION OF THE DEVICE. THE PHYSICIAN AGREED TO EXPLANT THE DEVICE, BUT A DATE WAS NOT SET AS OF THE DATE OF THIS REPORT. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S OUTCOME. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR LEAD: MODEL 3778, LOT# V753517033| EXPLANTED:| IMPLANTED:| RECHARGER: MODEL 37752, LOT# NKA151272N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE170777N| LEAD: MODEL 3778, LOT# V753517034