BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2000343 · Received February 18, 2011

    Report

    Report Number
    3004209178-2011-01237
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 1, 2009
    Report Date
    February 2, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED LACK OF EFFECT AND PRE-EXISTING PAIN. IT WAS UNK IF THE PROBLEM COULD BE ATTRIBUTED TO THE IMPLANTABLE NEUROSTIMULATOR SYSTEM. THE LEAD WAS REVISED (B)(6) 2009. REPROGRAMMING WAS DONE (B)(6) 2009 WITH INADEQUATE COVERAGE OF PAIN. THE PT STOPPED USING THE IMPLANTABLE NEUROSTIMULATOR. FOUR MONTHS LATER, THERE WERE COUPLING AND COMMUNICATION ISSUES BETWEEN THE RECHARGER AND NEUROSTIMULATOR. AN OVERDISCHARGE WAS SUSPECTED. THE STIMULATOR WAS EXPLANTED (B)(6) 2010, DUE TO INADEQUATE ANALGESIA.

    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 IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE119561N| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3776, LOT# V189122011| LEAD: MODEL 3776, LOT# V189122018