BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2021792 · Received February 25, 2011

    Report

    Report Number
    3007566237-2011-01451
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    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 THERE WAS RESISTANCE WHEN INSERTING THE LEAD INTO THE EXTENSION DESPITE UNTIGHTENING THE SCREW. AS A RESULT ALL IMPEDANCES WERE > 10,0000 OHMS. AFTER TRYING AGAIN, WHEN THE LEAD WAS INSIDE THE EXTENSION, ELECTRODES 1, 6 AND 7 WERE > 10,000 OHMS. THE OTHER ELECTRODES WERE "OK". PRIOR TO IMPLANTING THE EXTENSION, THE TESTING OF THE IMPEDANCES ON THE LEAD WENT WELL AND WERE "OK". THE IMPLANTER THOUGHT THE LEAD WAS TOO BIG FOR SAFE INSERTION INSIDE THE EXTENSION, BUT THE LEAD AND EXTENSION WERE STILL IMPLANTED BECAUSE THE PT HAD "GOOD" STIMULATION USING THE ELECTRODES THAT WERE OK. IN POST-OPERATIVE, ELECTRODES 1, 6, AND 7 WERE STILL > 10,000 OHMS. THE PT WAS "OK" WITH THE STIMULATION AND HAD NO REVISION NEEDS AT THE TIME. THE PT HAD NO INJURY AND THERE WERE NO ACTIONS REQUIRED AS A RESULT OF THE EVENT.

    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:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3876, LOT# 0204445736| EXTENSION: MODEL 37081, LOT# NJB087960V| EXPLANTED: