BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 9177049 · Received October 10, 2019

    Report

    Report Number
    3004209178-2019-19430
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    January 1, 2018
    Report Date
    November 6, 2019
    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
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVENT DATE IS APPROXIMATE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT#: V800435, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093-28, SERIAL/LOT #: (B)(4), UBD: 14-AUG-2015, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE REPORTED THAT THEY WERE NOT ABLE TO CLARIFY THE ¿THE PATIENT¿S SYSTEM BEING REWIRED IN (B)(6) 2018¿ AS THEY DID NOT WORK WITH THIS PHYSICIAN. THEY NOTED THAT THE PATIENT WAS AT THE HOSPITAL IN THEIR TERRITORY AND THE DOCTOR ON CALL HAD THEIR INFORMATION SO THE REPRESENTATIVE WAS CALLED. THE REPRESENTATIVE TOLD THE DOCTOR THAT THEY WOULD TRY TO TURN THE STIMULATOR OFF. THE CAUSE OF THE COMMUNICATION ISSUE WAS NOT DETERMINED. AS AN ACTION TAKEN TO RESOLVE THE COMMUNICATION ISSUE, THE REPRESENTATIVE TRIED MULTIPLE TIMES TO CONNECT WITH THEIR CLINICIAN PROGRAMMER AS WELL AS THE PATIENT¿S PROGRAMMER. NEITHER OF THESE DEVICES WERE READ THE INS DEVICE. IT WAS UNKNOWN WHAT FURTHER ACTIONS WERE TAKEN TO RESOLVE THE INS TURNING ITSELF ON AND OFF ALONG WITH SHOCKING THE PATIENT¿S BLADDER. THE REPRESENTATIVE ALSO REPORTED THAT IS WAS UNKNOWN IF THE ISSUES WERE RESOLVED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER AND A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT¿S INS WAS TURNING ITSELF ON AND OFF AND SHOCKING THEM THE BEGINNING OF (B)(6) LAST YEAR. THE PATIENT ALSO REPORTED THAT THEIR PROGRAMMER WAS SHOWING POOR COMMUNICATION DURING THIS TIME. THE PATIENT STATED THEY WENT TO SEE THEIR HEALTHCARE PROVIDER IN SEPTEMBER OF LAST YEAR WHO CHECKED THE INS AND TOLD THE PATIENT THAT THE LEAD WIRES WERE BROKEN. THE PATIENT STATED THE HEALTHCARE PROVIDER ¿REWIRED¿ THE SYSTEM AND TOLD THEM THAT IT WOULD LAST FOR A COUPLE OF YEARS. THE PATIENT STATED THEY HADN¿T NEEDED TO INS SO THEY KEPT IT TURNED OFF. THE PATIENT STATED THEIR REASON FOR CALLING WAS BECAUSE THEIR INS TURNED ITSELF BACK ON ON FRIDAY NIGHT AND WAS STARTING TO HURT. THE PATIENT TRIED USING THEIR PROGRAMMER TO TURN THEIR INS OFF BUT GOT THE POOR COMMUNICATION SCREEN. THE PATIENT PUT IN NEW BATTERIES AND REPORTED SEEING THE POOR COMMUNICATION SCREEN WITH THE ANTENNA. IT WAS REVIEWED THAT THE PROGRAMMER WAS NOT SYNCING WITH THE INS BECAUSE IT WAS LIKELY DEPLETED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO CHECK THE INS. ON 2019-SEP-24 A REPRESENTATIVE (REP) REPORTED THE PATIENT WAS EXPERIENCING SUDDEN SHOCKING AND THEY DIDN¿T KNOW IF THE STIMULATION WAS ON OR OFF. THE CALLER COULDN¿T COMMUNICATE WITH THEIR CLINICIAN PROGRAMMER OR THE PATIENT PROGRAMMER. THE PATIENT WAS CURRENTLY IN THE EMERGENCY ROOM BECAUSE OF A SHOCKING SENSATION IN THEIR BLADDER. TROUBLESHOOTING COULD NOT BE DONE DUE TO LACK OF ACCESS TO THE PRODUCT BUT TROUBLESHOOTING STEPS OF PALPATION ALONG SYSTEM OR X-RAYS/FLUOROSCOPY WERE REVIEWED. IT WAS ALSO REVIEWED THAT THE INS OR LEAD MAY BE IRRITATING A NERVE OR THE SHOCKING COULD BE RELATED TO SOMETHING ELSE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971617 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR