BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2870020 · Received December 12, 2012

    Report

    Report Number
    3004209178-2012-11739
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093, LOT # VA026J9, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (IPG 3058 INTERSTIM LL, SERIAL #(B)(4)) FOUND ITS SETSCREW HAD BEEN BACKED OUT TOO FAR. ANALYSIS OF THE LEAD (QUAD LEAD-SNS, TINED, EXTENDED E, LOT #VA026J9) FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE IMPEDANCES WERE >4,000 OHMS ON ALL COMBINATIONS USING ELECTRODE 0. THE LEAD WAS REPLACED AND THE ISSUE PERSISTED. THE BATTERY WAS THEN REPLACED AND THE ISSUE RESOLVED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. IT WAS REPORTED THAT THE PATIENT WAS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR