BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6401482 · Received March 13, 2017

    Report

    Report Number
    3004209178-2017-05530
    Event Type
    Injury
    Date Received
    March 13, 2017
    Date of Event
    February 14, 2017
    Report Date
    July 27, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AFTER FOLLOW-UP WITH THE PATIENT'S HCP IT WAS DETERMINED THAT FDD C62819 NO LONGER APPLIES. ADDITIONALLY THE LEAD IN NOW INCLUDED VIA SYSTEM REPORT WITH SAME FDD, FDP, AND FDC CODES. 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

    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

    THE MAIN COMPONENT OF THE SYSTEM AND THE OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# VA0XA48, IMPLANTED: (B)(6) 2016, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. 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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) MODEL 3058 SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES. THE DEVICE PASSED FUNCTIONAL TESTING AND LAB FUNCTIONAL TESTING DETERMINED THERE WAS GOOD STABLE OUTPUT ON ALL ELECTRICAL PAIRS AS RECEIVED. A TEST TO MONITOR THE TEMPERATURE OF THE INS DEVICE WAS PERFORMED AND SHOWED NO ANOMALIES WERE OBSERVED. ANALYSIS OF THE LEAD MODEL 3889-28 LOT # VA0XA48 SHOWED THAT CONDUCTORS #0 AND #3 WERE BROKEN IN THE BODY OF THE LEAD AT/NEAR THE TINES 5 CM FROM THE DISTAL END. CIRCUIT #0 WAS OPEN WAS CIRCUIT #3 WAS INTERMITTENTLY OPEN. NO ELECTRICAL SHORTS WERE OBSERVED. 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 PROVIDER (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. THE HCP STATED THAT THE PATIENT WAS ENCOUNTERING A "HOT SENSATION" LIKE THE PATIENT WAS SITTING ON A HOT PAD. THE INS WAS TURNED OFF AT THE TIME OF THE CALL. THE HEATING SENSATION WAS DESCRIBED AS INTERMITTENT AND IT WAS REPORTED THAT THE PATIENT HAD FALLEN, BUT THE DETAILS OF THE FALL WERE NOT KNOWN BY THE HCP. ADDITIONALLY IT WAS REPORTED THAT SITTING WAS WORSE. IMPEDANCES WERE TAKEN AT 2V 210 PW AND 14 HZ AND FOUND TO BE AS FOLLOWS: C0>4000, C1 1024, C2 683, C3 >4000, 01 >4000, 02 >4000, 03 >4000, 12 1995, 13 >4000, AND 23 > 4000. THE HCP WAS USING 12 CONFIGURATION FOR PROGRAMMING AND THE PATIENT CONFIRMED FEELING STIMULATION APPROPRIATELY WHEN STIMULATION WAS TURNED ON. ALSO IT WAS REPORTED THAT THE HEATING SENSATION WAS OCCURRING BOTH WITH AND WITHOUT STIMULATION. THE HCP ELECTED TO HAVE THE PATIENT KEEP A DIARY OF ACTIVITY AND LOCATION SO SEE IF THERE IS A PATTERN WITH SYMPTOMS. THE CHANGE WAS DESCRIBED AS SUDDEN, STARTING ABOUT 8-9 DAYS AGO. THERE WERE NO SIGNIFICANT WEIGHT CHANGES, REDNESS, ABNORMAL POCKET CONDITIONS, OR MOVEMENT OF THE INS IN THE POCKET OBSERVED BY THE HCP. PATIENT STATUS IS UNKNOWN AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE PATIENT'S HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT DID NOT FALL, BUT JUST SLIPPED AND DID NOT FALL TO THE GROUND. THE HCP STATED THAT THE DEVICE WAS TURNED OFF AND THERE WAS NO CHANGE IN PATIENT SYMPTOMS AND AGAIN STATED THAT THERE WERE HIGH IMPEDANECS. THE PATIENT WAS SCHEDULED FOR A REVISION OF THE LEAD AND POCKET WITH THE POSSIBILITY OF INS REPLACEMENT IF NEEDED. PATIENT STATUS IS UNKNOWN AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S HEALTHCARE PROVIDER (HCP) REPORTED THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT WAS (B)(6) LBS. NO FURTHER COMPLICATIONS WERE REPORTED/EXPECTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE HOT SENSATION AT THE POCKET WOULD RESOLVE WHEN THE DEVICE WAS TURNED OFF. THE DEVICE WAS REPLACED ON (B)(6) 2017. ON (B)(6) 2017, IT WAS REPORTED THAT THE REP RECEIVED THE IMPLANTED NEUROSTIMULATOR (INS) AND THE LEAD FROM THE CLINIC, NOTING THAT THEY ALSO REPLACED THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180866 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention