BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2924329 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00799
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# VA0422T, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (TINED LEAD, 3093-28 INTERSTIM,US 28 CM, LOT# VA0422T) FOUND ITS DISTAL END ELECTRODE HAD BEEN "PULLED OUT OR OFF." LEAD CONDUCTOR OBSERVATIONS SHOWED BROKEN CONDUCTOR(S) FROM OVERSTRESS/DAMAGE. CONDUCTOR CIRCUIT #0 WAS BROKEN. THE LOCATION OF CONDUCTOR BREAK WAS IN ELECTRODE AREA. ELECTRODE #0 SLEEVE WAS TORN OFF. LEAD'S DISTAL END WAS FOUND STRETCHED AND ITS TIP MISSING. FUNCTIONAL TEST REVEALED OPEN CIRCUITS AND NO SHORT CIRCUITS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS DAMAGED DURING AN IMPLANT PROCEDURE DUE TO POSITIONING DIFFICULTY. WHEN THE LEAD WAS INSERTED INTO THE INTRODUCER SHEATH, IT CURLED UP WITHIN THE SHEATH, BECAME 'FLEMRY' AND THE DISTAL TIP STARTED POINTING BACK UP IN THE SHEATH. THE HEALTHCARE PROVIDER (HCP) ATTEMPTED TO RETRACT, BUT THE LEAD GOT STUCK. THE REPORTER STATED THAT THE TINES APPEARED TO HAVE BEEN DEPLOYED TOO EARLY AS WELL, AS THERE WAS BLOOD AND TISSUE ON THE TINES. THE HCP HOWEVER INDICATED THAT THE LEAD WAS NEVER SENT OUT THE OTHER SIDE OF THE INTRODUCER. THE REPORTER INDICATED THAT IT COULD HAVE POSSIBLY BEEN A USER ERROR. THE LEAD WAS REMOVED IMMEDIATELY AND REPLACED. EVERYTHING WAS FINE AFTER THAT AND THE PATIENT WAS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30735 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR