BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1973644 · Received January 18, 2011

    Report

    Report Number
    3004209178-2011-00417
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 6, 2011
    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
    IN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO WHICH STATED THE PT HAS HAD A RED RASH ON HER NECK FOR ALMOST TWO YEARS. PT STATES WHEN SHE USES STIMULATION, THE RASH SEEMS TO BE WORSE. THE RASH IS ALSO WORSE WITH SUN EXPOSURE. PT WAS TOLD TO SEE A SPECIALIST AND ABOUT USE OF A MEDTRONIC ALLERGY KIT. PT ALSO INQUIRED IF HER SCS COULD AFFECT HER CELL PHONE AND TV. BOTH DEVICES HAVE STOPPED WORKING RECENTLY. MEDTRONIC'S PT SERVICES EXPLAINED TO THE PT IT WAS MORE LIKELY HER CELL PHONE AND TV WOULD AFFECT HER SCS. ADDITIONAL INFO REPORTED THE PT WAS EXPERIENCING A SHOCKING SENSATION NEAR THE BATTERY POCKET SITE AFTER BEING PUNCHED IN THAT LOCATION BY SOMEONE. SHE DOES NOT USE THE STIMULATION ANY MORE BUT DOES KEEP THE BATTERY CHARGED. PT DOES NOT HAVE MEDICAL INSURANCE SO SHE HAS NOT SEEN HER PHYSICIAN. IF ADDITIONAL INFO BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT.

    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 36 YR Female ACCESSORY: MODEL 37752, LOT # NKA119699N| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT # V102442002| PROGRAMMER: MODEL 37743, LOT # NKE117240N| STIM ACCESSORY: MODEL 3550-29, LOT # N140910| EXPLANTED:| LEAD: MODEL 3777, LOT # V102442002| IMPLANTED:| IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT # N140910| ACCESSORY: MODEL 37752, LOT # NKA119699N| PROGRAMMER: MODEL 37743, LOT # NKE117240N