BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2000369 · Received February 18, 2011

    Report

    Report Number
    3004209178-2011-01215
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTABLE NEUROSTIMULATOR AND LEAD HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED PAIN AND REDNESS AT THE RIGHT OCCIPITAL INCISION. THE AREA WAS INFECTED WITH COAGULASE NEGATIVE STAPHYLOCOCCUS. THE IMPLANTABLE NEUROSTIMULATOR SYSTEM WAS PROMPTLY REMOVED. THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention EXPLANTED:| LEAD: MODEL 3778, LOT# V382402014| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE138971N| STIM PLUG: MODEL 3550-39, LOT# UNKNOWN| IMPLANTED:| LEAD ANCHOR: MODEL 3550-09, LOT# UNKNOWN| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA132076N| IMPLANTED: