BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1801176 · Received August 11, 2010

    Report

    Report Number
    3004209178-2010-06019
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    June 2, 2010
    Report Date
    July 15, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS UNABLE TO ACTIVATE THE NEUROSTIMULATOR. THE PT WAS UNABLE TO RECHARGE THE NEUROSTIMULATOR. THERE WAS AN ANTENNA ERROR MESSAGE PRESENT ON THE PROGRAMMER. THE PT EXPERIENCED AN INCREASE IN HEADACHES. THE DEVICE WAS RECHARGED. A NEW NEUROSTIMULATOR WAS IMPLANTED. IT WAS STATED THAT THE ISSUE RESOLVED WITHOUT SEQUELAE. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention ACCESSORY: MODEL 37752, LOT# NKA131675N| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB000713N| EXTENSION: MODEL 37082, LOT# NKB001117N| EXTENSION: MODEL 37082, LOT# NKB001236V| EXTENSION: MODEL 37082, LOT# NKB016363N| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED: | LEAD: MODEL 3487A, LOT# J0437037V| LEAD: MODEL 3487A, LOT# V005005| LEAD: MODEL 3487A, LOT# V153223| LEAD: MODEL 3487A, LOT# V163758| EXTENSION: MODEL 37082, LOT# NKB001117N| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB000713N| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA131675N| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB016363N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V163758| EXTENSION: MODEL 37082, LOT# NKB001236V| LEAD: MODEL 3487A, LOT# V005005| LEAD: MODEL 3487A, LOT# V153223| LEAD: MODEL 3487A, LOT# J0437037V