BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3217691 · Received July 10, 2013

    Report

    Report Number
    3004209178-2013-11594
    Event Type
    Malfunction
    Date Received
    July 10, 2013
    Date of Event
    June 16, 2013
    Report Date
    October 4, 2018
    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
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 3037, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3093-33, LOT# V516895, IMPLANTED: (B)(6) 2010: PRODUCT TYPE LEAD; PRODUCT ID 3093-33, LOT# V526900, IMPLANTED: (B)(6) 2010: PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE HOSPITAL STAFF NEEDED TO KNOW HOW TO SHUT OFF THE DEVICE FOR A SURGICAL PROCEDURE. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A PACEMAKER 10 DAYS AGO AT THEIR CLINIC. TODAY ((B)(6) 2013) THE PATIENT SHOWED UP WITH A COMPLAINT THAT THE LEFT ONE (INTERSTIM) WAS BOTHERING. THERE WAS A WARNING SCREEN ON THE PROGRAMMER SCREEN AND SOMETHING THAT LOOKED LIKE A SYNC PROMPT. THIS STARTED YESTERDAY ((B)(6) 2013). IT WAS SUGGESTED TO CALL PATIENT SERVICES. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING AN OVERSTIMULATION SENSATION. A PERSON CALLED FROM THE PATIENT'S CARDIOLOGISTS OFFICE. THE PATIENT CAME TO THEIR OFFICE STATING SHE HAD AN ICON SHOWING ON HER REMOTE FOR THE LEFT. THE PATIENT DID NOT KNOW WHAT IT MEANT. THE PATIENT REQUESTED HELP LOWERING THE INS STIMULATION LEVEL. THERE WAS A WARNING SCREEN WITH THE SYNC ICON. THEY TRIED SYNCING WITH THE ANTENNA. POOR COMMUNICATION KEPT COMING UP. THEY UNPLUGGED THE ANTENNA AND HELD THE REMOTE AGAINST THE INS. THE REMOTE WAS REPOSITIONED SEVERAL TIMES BEFORE COMMUNICATION WAS SUCCESSFUL. THEY WERE WALKED THROUGH SYNCING, REPOSITIONING THE REMOTE, AND DECREASING STIM FROM 1.40 TO 1.0. THIS SETTING WAS MORE COMFORTABLE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318816 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR