BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2030930 · Received March 4, 2011

    Report

    Report Number
    9614453-2011-01662
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THAT TWO EXTENSIONS ATTACHED TO A 5-6-5 SURGICAL LEAD COULD NOT BE INSERTED INTO THE INS. THE FIRST CHANNEL (0-7) WAS NOT PERMEABLE. THE EXTENSION WOULD NOT ADVANCE BEYOND THE THIRD OR FOURTH ELECTRODE. BOTH EXTENSIONS WERE TRIED WITHOUT SUCCESS. A THIN METAL OBJECT WAS INSERTED INTO THE CHANNEL. THIS COULD BE ADVANCED ALL THE WAY, BUT EXPERIENCED SOME RESISTANCE IN THE SAME SPOT AS THE EXTENSION DID. THE INS WAS REPLACED WITH ANOTHER OF THE SAME MODEL AND WORKED FINE. NO HARM TO THE PATIENT AND PATIENT IS DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1