BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1910645 · Received November 19, 2010

    Report

    Report Number
    3004209178-2010-09829
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 11, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS UNABLE TO RECHARGE THE DEVICE. TROUBLESHOOTING BETWEEN THE PT AND A TECHNICAL SERVICE CONSULTANT REVEALED CHARGING BETWEEN 0 AND 25%. THE PT PROGRAMMER WAS WORKING. THE PT WAS REFERRED TO LOANER/REPAIR DEPARTMENT TO POSSIBLY GET A NEW RECHARGER, BUT DROPPED THE CALL. THE PT WAS SEEN BY THE FIELD REP. THE PT WAS CONFUSED ABOUT CHARGING. THERAPY WAS REPROGRAMMED SEVERAL TIMES. NO DEVICE ISSUES WERE NOTED. THE PT WAS IN A LOT OF PAIN AND FELL SEVERAL TIMES. THE PT'S FAMILY WAS NOT HAPPY WITH IMPLANTABLE NEUROSTIMULATOR THERAPY BECAUSE THEY THOUGHT THE DEVICE CAUSED THE PT TO FALL. THE DEVICE SYSTEM WAS REMOVED. THE PT HADN'T RETURNED TO THE DEVICE-MANAGING HCP POST OPERATIVELY.

    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 69 YR Required Intervention EXPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V362201| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE147860N| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V371343030| LEAD: MODEL 3888, LOT# V323526| EXTENSION: MODEL 37082, LOT# NKB001690V| ACCESSORY: MODEL 37752, LOT# NKA136811N| IMPLANTED:| IMPLANTED:| EXPLANTED: