BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2060937 · Received March 14, 2011

    Report

    Report Number
    3004209178-2011-01894
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE LEAD WAS 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 STILL FELT STIMULATION, BUT NO LONGER HAD ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT IMPLANTABLE NEUROSTIMULATOR REVISION SURGERY. THE NEW LEAD WAS PLACED AND CONNECTED TO THE EXISTING IMPLANTABLE NEUROSTIMULATOR. IMPEDANCES WERE NORMAL. WHEN THE NEW IMPLANTABLE NEUROSTIMULATOR WAS CONNECTED, IMPEDANCES WERE GREATER THAN 10,000 OHMS. THE EXTENSIONS WERE DISCONNECTED FROM THE IMPLANTABLE NEUROSTIMULATOR, THEN RECONNECTED. IMPEDANCES REMAINED HIGH FOR CONTACTS 0 TO 1. THE LEAD WAS THEN CONNECTED TO A SNAP LID CONNECTOR AND EXTERNAL NEUROSTIMULATOR WITH THE SAME RESULTS. THE LEAD WAS REPLACED. IMPEDANCES WERE NORMAL. THE PATIENT WAS GETTING GOOD PAIN RELIEF WITH THE NEW LEADS AND IMPLANTABLE NEUROSTIMULATOR. THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    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 45 YR Female ACCESSORY: MODEL 37752, LOT# NKA146883N.| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3986A, LOT# N118135.| LEAD: MODEL 3986A, LOT# N254624.| PROGRAMMER: MODEL 37743, LOT# NKE157825N.| STIM ACCESSORY: MODEL 37092, LOT# 217030003.| ACCESSORY: MODEL 37752, LOT# NKA146883N| LEAD: MODEL 3986A, LOT# N254624| IMPLANTED:| IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 217030003| PROGRAMMER: MODEL 37743, LOT# NKE157825N| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3986A, LOT# N118135| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: