BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6045576 · Received October 20, 2016

    Report

    Report Number
    3004209178-2016-22242
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    June 27, 2016
    Report Date
    December 7, 2016
    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
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# VA18AC6, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3093-33, LOT# V062019, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. ANALYSIS OF THE INS (SERIAL # ) FOUND THAT THERE WAS LEAD PART(S) STUCK IN THE CONNECTOR PORT. ANALYSIS OF THE LEAD (SERIAL # ) FOUND THAT THE STIM LEAD BODY WAS STRETCHED. METHOD CODES ONLY APPLY TO THE LEAD. A SEGMENT OF THE CONNECTOR BLOCK WAS CUT AWAY TO REMOVE THE LEAD SEGMENT STUCK IN THE CONNECTOR BLOCK. DUE TO CONNECTING THE CONNECTOR BLOCK, THE INS WAS UNABLE TO BE TESTED. RESULT CODE REFERS TO THE LEAD. RESULT CODE REFERS TO BOTH THE INS AND LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# VA18AC6, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3093-33, LOT# V062019, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH, NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT WAS GETTING THEIR BATTERY REPLACED ON (B)(6) 2016 AND DURING THE SURGERY THE NEW INS AND LEAD WERE IMPLANTED AND THE LEAD WAS CHECKED AND NOTED TO NOT BE WITHIN NORMAL LIMITS. THE LEAD WAS ATTEMPTED TO BE REMOVED FROM THE NEW INS AND IT WOULD NOT COME OUT. EVENTUALLY THE HCP PULLED HARD ENOUGH THAT THE CASING OF THE LEAD PULLED BACK EXPOSING THE INTERNAL LEAD WIRES. AT THAT POINT THE HCP DID NOT HAVE ANY SUPPLIES TO REPLACE THE LEAD. THE NEW INS AND BROKEN LEAD WERE LEFT IN THE BODY. IT WAS NOTED THAT THE LEAD AND NEW INS WERE LEFT IN THE BODY SO THAT ONCE THE HCP CAME BACK TO REPLACE THE LEAD, THE HCP COULD GO BACK TO SAME POSITION. ON (B)(6) 2016 THE PATIENT CAME BACK TO HAVE THE ENTIRE SYSTEM REPLACED AND THIS OCCURRED WITHOUT ANY PROBLEMS. THE OLD SYSTEM WAS EXPLANTED SUCCESSFULLY. THE NEW SYSTEM WAS WORKING WITHIN NORMAL LIMITS. NO PATIENT SYMPTOMS WERE REPORTED. THE PATIENT STATUS WAS ALIVE, NO INJURY AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695492 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention