BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4162039 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19414
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    September 19, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT WAS REMOVED AND WAS ADDED. CONCLUSION CODE WAS REMOVED AND WAS ADDED.

    Additional Manufacturer Narrative · 1

    UPON DEVICE RETURN, ANALYSIS FINDING OF LEAD SERIAL NUMBER (B)(4) REVEALED AT THE PROXIMAL END OF THE CONDUCTOR A SHORT BETWEEN CIRCUITS (DRY CONDITIONS). A SHORT WAS PRESENT UNDER THE NUMBER 0 CONNECTOR SLEEVE ON THE PROXIMAL END. THE OUTER INSULATION WAS BROKEN AT 5.1CM (CENTIMETER) FROM DISTAL END. ALL CONDUCTORS WERE CRUSHED AT 5.1 AND 6.5 CM FROM DISTAL END. THE FUNCTIONAL TEST REVEALED CONTINUITY ACCEPTABLE. SHORTS BETWEEN CIRCUITS 0-2, 0-3, AND 2-3. X-RAY OF THE LEAD SHOWED NUMBER 0 CONDUCTOR WIRE WAS TOUCHING OTHER CONDUCTOR WIRES IN THE NUMBER 0 CONNECTOR SLEEVE. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# V840309, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THERE WAS NO PERMANENT IMPAIRMENT. THE HCP DID PERFORM A LEAD REVISION IN (B)(6) FOR THE PATIENT, BUT SHE WAS DOING WELL WITHOUT COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS BROKEN AND THERE WAS A LOW IMPEDANCE VALUE, LESS THAN 50 OHMS, ON THE ELECTRODE COMBINATION OF 0 AND 3. THE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE REPLACED. AS OF (B)(6) 2014 THE MANUFACTURER REPRESENTATIVE HAD NOT SEEN THE PATIENT FOR FOLLOW-UP. THE PATIENT OUTCOME WAS NOT REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT RECOVERED WITH PERMANENT IMPAIRMENT. THE IPG (STIMULATOR) AND LEAD WERE REVISED. THERE WAS A SHORT IN ONE OF THE ELECTRODES. SENT BOTH LEAD AND IPG TO MANUFACTURER FOR FURTHER EVALUATION. THE LEAD AND STIMULATOR WAS EXPLANT ON (B)(6) 2014. ADDITIONAL INFORMATION WAS REQUESTED FOR THE PERMANENT IMPAIRMENT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643901 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention