BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3982209 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13998
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V219500, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # V219500, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEA DS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION ((B)(4) 2010).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SUCCESSFUL TRIAL AND WENT TO IMPLANT. IMPLANT WAS NOT SUCCESSFUL ACCORDING TO THE PATIENT AND THE DOCTOR DID A LEAD REVISION ¿ AT THAT REVISION HE WAS UNABLE TO RETRIEVE THE ENTIRE LEAD (A FRAGMENT WAS LEFT IN THE PATIENT) . HISTORY AND PHYSICAL FROM (B)(6) 2009 NOTED: THE PATIENT HAD NOT HAD AS SIGNIFICANT BENEFIT AS COMPARED TO THE PERCUTANEOUS PROCEDURE. IN TRYING VARIOUS DIFFERENT PROGRAMMING SETTINGS, THE DECISION WAS TO REPLACE AND REVISE THE INTERSTIM LEADS. URINARY FREQUENCY WAS NOTED. OPERATIVE REPORT FROM (B)(6) 2009 NOTED: FREQUENCY, REVISION OF INTERSTIM WITH NEW LEAD PLACEMENT. IN THE INITIAL PART OF THE PROCEDURE, THE FLUOROSCOPY REVEALED THAT THE RIGHT SIDED LEAD APPEARED TO BE MORE LATERALLY PLACED THAN WOULD ASSUMED. THIS MAY ACCOUNT FOR THE LACK OF EFFICACY BASED ON THE LEAD ITSELF. IT WAS NOTED THAT THEY ATTEMPTED TO RELEASE THE LEAD, IT WAS DIFFICULT TO REMOVE AND ONCE IT WAS REMOVED THE ACTUAL TINED LEAD ITSELF WAS STILL WITHIN THAT AREA , BUT THE DECISION WAS TO SIMPLY LEAVE IT THERE. IT WAS LIKELY SECONDARY TO THE ANGULATION OF IT, WHICH WAS DIFFICULT TO REMOVE. A NEW LEAD WAS PLACED AT THE REVISION AND WAS COMPLETELY REMOVED WHEN THE PATIENT HAD THE SYSTEM EXPLANT IN (B)(6) 2010 . IT SOUNDED LIKE THE PATIENT REQUESTED THE REMOVAL DUE TO IT NOT PROVIDING THE AMOUNT OF EFFECT THEY EXPECTED. THE INTERSTIM DEVICE WAS REMOVED IN (B)(6) 2010. THE DEVICE WAS REMOVED BECAUSE IT WASN'T WORKING. THE PATIENT STILL HAD FREQUENT URINATION AND THE DEVICE DIDN'T HELP. IT WAS NOTED THAT THE PATIENT HAD AN XRAY OF HER TAILBONE DONE ON (B)(6) AND SHE GOT THE RESULTS FROM THE XRAY ON (B)(6). THE XRAY SHOWED A LEAD FRAGMENT STILL INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456890 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR Required Intervention