BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4977180 · Received August 6, 2015

    Report

    Report Number
    3004209178-2015-15579
    Event Type
    Injury
    Date Received
    August 6, 2015
    Report Date
    February 28, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-33, LOT# V240181, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    A PATIENT AND HEALTHCARE PROVIDER REPORTED THAT THE PATIENT HAD PAIN AT THE IMPLANT SITE. SHE'D HAD A DEVICE FOR OVER 10 YEARS AND IT HAD BEEN SWITCHED BACK AND FORTH. HER HEALTHCARE PROVIDER INFORMED HER THAT THERE WAS NOTHING MORE THEY COULD DO FOR PATIENTS LIKE HER WITH SEVERE ISSUES. SHE MAY NEED "SEVERE PLASTIC SURGERY" ON HER BUTT BECAUSE IT WAS ALL CONCAVED. IT WAS GETTING TO THE POINT WHERE IT HURT, THERE WAS NO FAT THERE, AND IT WAS GETTING UNCOMFORTABLE. PRIOR TO (B)(6) 2014 IT HAD BEEN THAT WAY FOR A WHILE, ABOUT SIX MONTHS. THE PATIENT WASN'T A BIG PERSON AND WHEN SHE WAS TRYING TO DO SIT-UPS ON (B)(6) 2014, SHE COULDN'T DO THEM BECAUSE IT HURT TO SIT DOWN. LATER, THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY, BUT WAS WORKING WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE. SHE HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2014. DIAGNOSTICS INCLUDED IMPEDANCE AND REPROGRAMMING ATTEMPTED ON (B)(6) 2014. IT WAS DETERMINED THAT THE DEVICE BATTERY WAS DEAD AND THE LEAD WAS "DINGED." A NEW LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE PLACED ON (B)(6) 2014. THIS WAS VERY DIFFICULT AND WAS POSSIBLY THE PATIENT'S FOURTH REVISION. THE NEW LEAD WAS SUCCESSFULLY PLACED AND THE PATIENT MAY NEED FURTHER PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520853 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention