BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1972403 · Received January 24, 2011

    Report

    Report Number
    3004209178-2011-00559
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 11, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PT WAS NOT ABLE TO ADJUST STIMULATION EVEN WHEN THE ANTENNA WAS ATTACHED. THE ANTENNA WIRES WERE FRAYED. THERE WERE COUPLING AND OR COMMUNICATION ISSUES. SHE WAS ABLE TO GET 4 SHADE COUPLING BARS. THE PT COVERED HER RECHARGER WHILE RECHARGING. THE NEUROSTIMULATOR (INS) WAS IMPLANTED DEEPER THAN THE DOCTOR WANTED. IT WAS LATER REPORTED THAT THE PT HAD SURGICAL INTERVENTION ON (B)(6) 2010 TO FIX THE PROBLEM WITH HER DEVICE. ADD'L INFO WAS REQUESTED.

    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 26 YR Required Intervention LEAD: MODEL 3986A, LOT# N198394| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA132756N| PROGRAMMER: MODEL 37743, LOT# NKE142349N| IMPLANTED:| LEAD: MODEL 3986A, LOT# N231803