BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4252126 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21655
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 27, 2014
    Report Date
    November 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_PROG, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN; PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS ((B)(4)) FOUND THAT THE SETSCREW WAS BACKED OUT TOO FAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT, THERE WAS AN IMPLANTABLE NEUROSTIMULATOR (INS) MALFUNCTION AND THE LEAD WOULD NOT ADVANCE COMPLETELY INTO THE INS. THE DOCTOR TRIED TO BACK OUT THE SET SCREW, AND THE FARTHEST THE LEAD WOULD ADVANCE WAS THREE QUARTERS OF THE WAY TO THE END. THE LEAD MADE IT PAST THE SET SCREW, BUT NOT TO THE END. THE DOCTOR TRIED ROTATING THE DEVICE FOR DIFFERENT ENTRY. IMPEDANCE TESTING WAS DONE AND THERE WERE HIGH IMPEDANCES GREATER THAN 4000 OHMS ON ALL ELECTRODES. THE ISSUE WAS NOT RESOLVED, AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE DEVICE WAS NOT IMPLANTED. THE PROCEDURE ENDED UP BEING JUST A LEAD REVISION INSTEAD OF A FULL REVISION AS PLANNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT REPLACEMENT OF THE INS WENT WELL AND THE PATIENT WAS RECEIVING THERAPEUTIC EFFECT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE NEW LEAD WAS PLACED AND IT WOULD NOT GO INTO THE NEW BATTERY SO THE OLD BATTERY WAS PUT BACK IN AND WAS PROVIDING CURRENT THERAPY FOR THE PATIENT. THE PATIENT WAS ABLE TO FEEL STIMULATION WITH THE OLD BATTERY AND NEW LEAD; HOWEVER THEY HAD TO INCREASE THE SETTINGS DUE TO THE AGE OF THE BATTERY. THE OLD BATTERY WOULD NEED TO BE REPLACED IN THE NEAR FUTURE DUE TO NORMAL BATTERY DEPLETION. AS THE NEW LEAD FIT INTO THE OLD BATTERY, THE NEW BATTERY THAT WAS USED WAS RETURNED FOR ANALYSIS. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738061 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention