BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4130331 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-18015
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 8, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V386952, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INDICATED THAT INTERSTIM HAD NOT WORKED FOR PATIENT SINCE IMPLANT. IT WAS STATED THAT "THERE WERE MANY YEARS OF CALL THE TECH, SEE THE TECH, THE TECH FIXES OR DEALS WITH, THIS WENT ON FOR QUITE A WHILE, AND FINALLY FRANKLY THOUGHT JUST DECIDED TO THE HECK WITH IT." THE PATIENT DID KNOW THE STIMULATION HAD BEEN TURNED OFF FOR QUITE A WHILE. IT WAS INDICATED THAT PATIENT HAD NOT BEEN FEELING STIMULATION FOR EASILY A COUPLE OF MONTHS. IT WAS NOTED THAT THE PATIENT KEPT GETTING POOR COMMUNICATION ON HER PATIENT PROGRAMMER. SHE HAD TRIED MOVING PROGRAMMER AROUND AND SHE WAS STILL GETTING POOR COMMUNICATION. THIS HAD BEEN GOING ON FOR ABOUT A MONTH AND PATIENT HAD NOT TRIED USING PROGRAMMER WITH ANTENNA FOR QUITE SOME TIME. IT WAS LATER REPORTED ON (B)(6) 2014-09-08 THAT PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT HAVE NOT SOUGHT FURTHER HELP. THE MENTIONED IT MAY BE A SAFE DEVICE BUT IT WAS SURE NOT EFFECTIVE BECAUSE AFTER 41/2 YEARS, DEVICE WAS DEAD AND NEVER WORKED. THE PATIENT MENTIONED THAT THE HEALTH CARE PROVIDER SAID IT USUALLY LASTED 7 TO 10 YEARS. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608263 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR