BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2092412 · Received May 2, 2011

    Report

    Report Number
    3004209178-2011-03189
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 13, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN IMPLANT PROCEDURE, HIGH IMPEDANCES (>40,000 OHMS AT 3 VOLTS) WERE SEEN ON MULTIPLE CONTACTS (#0, 3, 4, 8, AND 10). THE LEAD WAS REMOVED FROM THE DEVICE, WIPED CLEAN, AND THE DEVICE OPENINGS SUCTIONED WITH NO CHANGE IN IMPEDANCES. THE CONTACTS WERE THEN REMOVED AND TESTED IN A MULTI-LEAD TRIALING CABLE WITH NORMAL IMPEDANCES SEEN. WHEN THE LEADS WERE RE-CONNECTED AGAIN TO THE NEUROSTIMULATOR, HIGH IMPEDANCES WERE MEASURED. IT WAS DECIDED TO THEN USE A NEW STIMULATOR DEVICE AT WHICH TIME NORMAL IMPEDANCES WERE SEEN. NO INJURIES WERE REPORTED AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    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 50 YR LEAD: MODEL 39565-65, LOT# V651972011| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE165250N| IMPLANTED:| STIM ACCESSORY: MODEL 3555-31, LOT# UNK| ACCESSORY: MODEL 37752, LOT# NKA151391N