BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2162067 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-05331
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 17, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PROBLEMS WITH THE LEADS "BENDING." THE STIMULATION WAS INTERMITTENT. WHEN THE STIMULATION WAS WORKING, THE PATIENT EXPERIENCED IMPROVEMENT IN THE SYMPTOMS WHILE WALKING. THE PATIENT HAD BOTH DRUG DELIVERY AND NEUROSTIMULATION THERAPIES. IT WAS LATER REPORTED THAT THE PATIENT LOST STIMULATION TO THE AFFECTED AREA. THERE WAS DISLODGEMENT/MIGRATION OF THE PATIENT'S LEAD CAUSED BY THE PATIENT'S "BENDING, TWISTING, AND LIFTING." THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. A REVISION OF THE PATIENT'S LEAD WAS PERFORMED. THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE EVENT. THE PATIENT'S INJURY WAS NOTED TO BE NON-SERIOUS. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S OUTCOME. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION 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 45 YR Hospitalization| R EXPLANTED:| LEAD: MODEL 39565-65, LOT# V548213013| RECHARGER: MODEL 37752, LOT# NKA148994N| PROGRAMMER: MODEL 37743, LOT# NKE156957N| IMPLANTED: