BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1870464 · Received October 11, 2010

    Report

    Report Number
    3004209178-2010-07794
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    May 15, 2006
    Report Date
    September 14, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD SHOCKING SENSATION SINCE IMPLANT OF THIS DEVICE. APPARENTLY, THE DOCTOR SAID DO NOT USE UNTIL SHE COULD GET A NEW BATTERY REPLACED. WHEN THE NEW BATTERY WAS IMPLANTED, THE IMPEDANCE WAS STILL HIGH AND NO STIMULATION. THE SURGEON WAS AWARE OF THIS AND SAID HE WOULD REFER HER TO SOMEONE ELSE TO REPLACE THE LEADS. THERE WAS NO FURTHER CONTACT FROM THIS PHYSICIAN. PLEASE REFER TO MANUFACTURER REPORT #3004209178201006450 AND REPORT #3004209178201007793.

    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 52 YR Required Intervention LEAD: MODEL 3487A, LOT #J0114019V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT #NKA142506N| LOT #NAT149099H| IMPLANTABLE NEURO STIMULATOR: MODEL 7425,| STIM ACCESSORY: MODEL 37092, LOT #252640002| IMPLANTED:| LOT #NAT154459H| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7425,| EXTENSION: MODEL 7495-51, LOT #XR0005342V| PROGRAMMER: MODEL 37743, LOT #NKE150405N