BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1930305 · Received November 24, 2010

    Report

    Report Number
    3007566237-2010-09945
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A LEAD ON (B)(6) 2010 FOR A TRIAL. EVERYTHING WENT WELL DURING THE TRIAL. ON (B)(6) 2010, THE PATIENT HAD SURGERY FOR A PERMANENT DEVICE IMPLANT. WHEN THE PHYSICIAN TRIED TO INSERT THE PERMANENT EXTENSION, AFTER UNTIGHTENING THE SCREW, THERE WAS ENOUGH RESISTANCE, SO THAT IT WAS IMPOSSIBLE FOR THE IMPLANTER TO PUSH THE ELECTRODE CONNECTOR INTO THE BOTTOM OF THE EXTENSION CONNECTOR. AS A RESULT, ALL IMPEDANCES WERE GREATER THAN 10,000 OHMS. AFTER THE CONNECTOR WAS INSIDE THE EXTENSION, THE IMPEDANCE OF THE CONTACT # 7 WAS GREATER THAN 10,000 OHMS AND ALL OTHER ELECTRODES WERE OK. THE SURGERY WAS COMPLETED WITH GOOD STIMULATION WITH CONTACTS 0+1-2+ AND CONTACT # 7 WAS NOT NEEDED FOR STIMULATION COVERAGE. POST-OPERATIVELY, IMPEDANCE MEASUREMENTS SHOWED CONTACT 1, 2 AND 7 WERE GREATER THAN 10,000 OHMS. THE PHYSICIAN TURNED ON THE DEVICE THE FOLLOWING DAY WITH THE SAME IMPEDANCE RESULTS. NO REVISION WAS PLANNED AS THE PATIENT APPEARED TO HAVE GOOD STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC NEUROMODULATION 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB077943V| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3877, LOT# 0203851292