BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4202429 · Received October 27, 2014

    Report

    Report Number
    3004209178-2014-20401
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0DY97, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PELVIC AND TAILBONE PAIN. THE PATIENT WAS TOLD BY THEIR SURGEON TO TURN OFF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR 2 WEEKS TO SEE IF THE PAIN WENT AWAY. DIAGNOSTICS AND TROUBLESHOOTING THAT WERE PERFORMED INCLUDED IMPEDANCE TESTING. IF THE PAIN GOES AWAY, THE PATIENT WAS TO HAVE A LEAD REVISION. IT THE PAIN DID NOT GO AWAY THE PATIENT WAS GOING TO SEEK HELP FROM THEIR PRIMARY CARE PHYSICIAN (PCP). THE PATIENT REPORTED THAT THEY TURNED THE INS OFF A FEW DAYS AGO AND THE PAIN HAD NOT GONE AWAY. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. IT WAS FURTHER REPORTED THAT THE PATIENT HAD DECIDED TO LEAVE THEIR IMPLANT OFF FOR THE PRESENT TIME. THE PATIENT WAS EXPERIENCING PAIN WITH THE IMPLANT TURNED OFF AND WAS WORKING WITH THEIR HEALTH CARE PROVIDER (HCP) TO FIGURE OUT THE ROOT ISSUE. THE PATIENT WOULD CONTACT THEIR HCP IF AND WHEN THEY DECIDED TO TURN THEIR IMPLANT BACK ON. THE MANUFACTURER REPRESENTATIVE SPOKE WITH THE PATIENT AND THEY HAD THEIR IMPLANTED TURNED OFF FOR MORE THAN A WEEK AND STILL FELT SOME PAIN THAT THEY DESCRIBES AS ¿BUTT BONE¿ NOT TAILBONE. THE PATIENT JUST COMPLETED TREATMENT FOR A URINARY TRACT INFECTION (UTI) AND WAS HAVING SEVERE ISSUES WITH ARTHRITIS THROUGHOUT THEIR BODY. THE PATIENT¿S HCP ADVISED THEY KEEP THEIR IMPLANT TURNED OFF UNTIL THEY SAW THEIR PCP, ARTHRITIS HCP, AND GOT A FLAT PLATE X-RAY OF THEIR PELVIS TO VERIFY LEAD PLACEMENT. THE PATIENT WAS IN THE PROCESS OF SCHEDULING THESE APPOINTMENTS AND WOULD FOLLOW-UP WITH THEIR HCP AND MANUFACTURER REPRESENTATIVE AFTER THEY HAD MORE INFORMATION. NO OUTCOME OR INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A 50 PERCENT OR GREATER SYMPTOM REDUCTION. THE PATIENT HAD BUTTOCK PAIN AND WAS SEEING A RHEUMATOLOGIST AND AN ORTHOPEDIC HCP. THE TROUBLESHOOTING DONE TO PROVIDE INSIGHT TO THE ISSUE WAS AN X-RAY AND THE LEAD WAS IN PERFECT POSITION. THE ACTION TAKEN TO RESOLVE THE ISSUE WAS THAT THE PAIN MAY NOT BE SECONDARY TO THE DEVICE. THE CAUSE OF THE EVENT WAS NOT DETERMINED AND IT WAS UNKNOWN IF IT WAS DEVICE RELATED. THE HCP WAS UNCERTAIN OF THE CAUSE FOR THE PAIN AND THE PATIENT WAS BETTER NOW. THE PATIENT WAS NOT RECOVERED AND HAD SYMPTOMS OR AN ISSUE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682305 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention