BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7724087 · Received July 26, 2018

    Report

    Report Number
    3004209178-2018-16764
    Event Type
    Malfunction
    Date Received
    July 26, 2018
    Date of Event
    July 11, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# 0215376171, IMPLANTED: (B)(6) 2018, PRODUCT TYPE LEAD. PLEASE NOTE THE PMA NUMBER HAS BEEN UPDATED FROM P970004 TO P080025 AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTED THE IMPLANTING SURGEON TRIED TO FEED THE LEAD INTO THE HEADER BLOCK BY UNSCREWING THE SET SCREW AND HAD ALSO TRIED TO FEED THE LEAD INTO THE INS WHILE USING DIFFERENT INS ORIENTATIONS. THE ISSUE OCCURRED DURING THE IMPLANT OF A NEW INS WITH AN EXPERIENCED IMPLANTING SURGEON. THE INS WAS REPLACED WITH A SECOND NEW INS AS A RESULT OF THE ISSUE AND THE LEAD WAS FED INTO THE SECOND INS WITHOUT ISSUE. IT WAS NOTED THE PATIENT¿S LEAD WAS IMPLANTED ON (B)(6) 2018 AS THE FIRST STAGE OF AN ADVANCED TRIAL AND THAT THE (SECOND) INS WAS IMPLANTED AT THE SECOND STAGE ON (B)(6) 2018. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED. IT WAS NOTED THE PATIENT¿S INDICATION FOR DEVICE USE WAS FECAL URGENCY, FREQUENCY, AND INCONTINENCE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THE DEVICE PASSED ALL TESTING IN THE LABORATORY AND NO ANOMALIES WERE IDENTIFIED. IT WAS NOTED THAT, DUE TO THE REPORTED COMPLAINT, A LEAD INSERTION TEST WAS PERFORMED ON THE INS. INSERTION AND WITHDRAWAL WAS PERFORMED 3 TIMES WITH A DRY LEAD, AND FOUND TO BE WITHIN SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) REPORTED VIA THE MANUFACTURER REPRESENTATIVE (REP) THAT THEY WERE UNABLE TO FEED THE LEAD INTO THE I MPLANTABLE NEUROSTIMULATOR (INS) HEADER BLOCK ON THE DAY OF THE REPORT. THEY ATTEMPTED UNSCREWING THE SET SCREW, AND ATTEMPTED SCREWING IN AND THEN UNSCREWING THE SET SCREW. HOWEVER, THE BLOCKAGE SEEMED TO BE FURTHER IN THE HEADER BLOCK CHANNEL THAN THE SET SCREW. THERE WERE NO KNOWN CONTRIBUTING FACTORS. IT WAS INDICATED THAT THE INS WAS NOT USED, AND A NEW INS WAS OPENED AND GIVE TO THE SURGEON FOR IMPLANT. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567095 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR