BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2021746 · Received February 25, 2011

    Report

    Report Number
    3004209178-2011-01433
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 10, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4),

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A BURNING AND STINGING SENSATION AROUND THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SITE FOLLOWING A FALL. IT WAS STATED THE PT FELL SOMETIME NEAR THE END OF (B)(6) 2011. ON (B)(6) 2011, THE PT REPORTED FEELING A "SEVERE BURNING/STINGING" AT THE INS SITE. THE PT WAS SCHEDULED TO F/U WITH THEIR HEALTH CARE PROVIDER. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO 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 56 YR IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE115251N| EXTENSION: MODEL 37081, LOT# NJB040821V| LEAD: MODEL 39565-30, LOT# N164854001| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA117767N| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB035976V| IMPLANTED:| IMPLANTED: