BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3242455 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12145
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # VA09HD8, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED A SETSCREW HAD BACKED OUT TOO FAR, BUT IT WAS NOTED IT WAS NOT CLEAR THAT THIS ISSUE WAS RELATED TO THE REPORTED EVENT. IT WAS ALSO NOTED THAT A SETSCREW WAS IMPRESSING ON THE #0 CONNECTOR ON THE LEAD INDICATED THAT THE SETSCREW MAY HAVE BEEN TIGHTENED DOWN AT ONE POINT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE HIGH IMPEDANCES, GREATER THAN 4000 OHMS, ON ALL CONTACTS WITH ELECTRODE 0 WHEN TESTED AT 1.7 VOLTS, 450 PULSE WIDTH, AND 14 HERTZ. INITIALLY IMPEDANCES WERE TESTED AT DEFAULT AND ALL THEY SAW WAS ¿???¿ AND GREATER THAN 4000 OHMS. IT WAS NOTED CURRENT IMPEDANCE MEASUREMENTS WERE NORMAL ON THE OTHER CONTACTS. THE REPRESENTATIVE HAD TRIED REPROGRAMMING BUT THE PATIENT WAS NOT FEELING ANYTHING AT 5 VOLTS USING ANY OF THE FOLLOWING COMBINATIONS: 1/3, 1/2, 2/3, C/2, C/3. IT WAS NOTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SOAKED IN BACITRACIN PRIOR TO IMPLANT. IT WAS ALSO NOTED THEY HAD SEEN ¿GREAT BELLOWS¿ AND TOE RESPONSE. ADDITIONAL INFORMATION RECEIVED THE SAME DAY REPORTED THERE WERE POST-OPERATIVE HIGH IMPEDANCES, GREATER THAN 4000 OHMS, ABOUT A HALF HOUR AFTER THE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE IMPLANTED. THE PARAMETERS WERE INCREASED AND THE HIGH IMPEDANCES RE SOLVED; A MANUFACTURER REPRESENTATIVE INCREASED THE VOLTAGE TO 1.7 VOLTS AND PULSE WIDTH TO 450 AND IMPEDANCES WERE 800 OHMS AND AROUND 1500 FOR UNIPOLAR PAIRS, HOWEVER THE PATIENT WAS NOT FEELING STIMULATION. IT WAS NOTED THE INS WAS PLACED IN SALINE PRIOR TO IMPLANT. THE PATIENT¿S SETTINGS WERE TO BE SET AND SHE WAS GOING TO BE SENT HOME AND EVALUATED AT A LATER DATE. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY 3 WEEKS LATER REPORTED THE POSSIBLE CAUSE WAS SALINE HAD GOTTEN INTO THE DEVICE. A REPLACEMENT WAS PLANNED FOR (B)(6) BECAUSE THE PATIENT WAS STILL NOT RECEIVING THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR HAD AN OUT OF BOX FAILURE. IT WAS REPORTED THE LEAD DID NOT FIT IN THE STIMULATOR. A DIFFERENT STIMULATOR WAS USED WITHOUT ISSUE. UPON FURTHER REVIEW, MANUFACTURER REPORT NUMBER 3007566237-2015-00325 IS THE SAME EVENT AS MANUFACTURER REPORT NUMBER 3004209178-2013-12145. ANY ADDITIONAL INFORMATION RECEIVED PERTAINING TO MANUFACTURER REPORT NUMBER 3007566237-2015-00325 WILL BE REPORTED IN MANUFACTURER REPORT NUMBER 3004209178-2013-12145.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343833 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention