BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4365007 · Received December 29, 2014

    Report

    Report Number
    3004209178-2014-24572
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 4, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V890309, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS USING A TENS UNIT TO TREAT POSSIBLE SCIATIC NERVE PAIN. THE PATIENT THOUGHT IT WAS SCIATIC, BUT NOT AT THE TIME THEY CALLED A FEW DAYS AGO. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) THOUGHT IT WAS MUSCULAR SKELETAL THING AND THEY DIDN¿T BELIEVE IT WAS SCIATIC PAIN AND IT WAS KIND OF LOW. TO THE PATIENT IT DID SEEM LIKE SCIATIC PAIN, BUT IT DIDN¿T RUN ALL THE WAY DOWN THEIR LEG. THE HCP HAD STATED FOR IT TO BE SCIATIC, THE PAIN COULDN¿T BE LOCALIZED. THE PAIN WAS VERY CLOSE TO THEIR SPINE, BUT IT DIDN¿T SEEM TO GO ANYWHERE AND JUST SEEMED TO STAY IN 1 AREA. THE PAIN WAS ON THEIR LEFT SIDE. THE PAIN IN THE SMALL AREA OF THEIR BACK THAT WAS KILLING THEM WASN¿T THAT BAD YET, BUT THE PATIENT WOULD SPEAK TO THEIR HCP REGARDING THIS. THE BACK PAIN WAS RELATED TO THEIR SCIATIC PAIN. YESTERDAY THE PATIENT ENDED UP DOING SOME LIFTING AND NOW HAD PAIN ON THEIR RIGHT SIDE. THE PATIENT WANTED TO KNOW IF THEY COULD USE THE TENS UNIT ON THEIR RIGHT SIDE. THE PATIENT HAD HAD FIBROMYALGIA IN THE PAST, AND THA T WAS ALL OVER THEIR BODY, WHICH REALLY INCAPACITATED THEM. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856321 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR