BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3133707 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08231
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 6, 2013
    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 3093-28, LOT # J0519553V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_PTM_PROG, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN OVERSTIMULATION SENSATION, STIMULATION IN THE WRONG LOCATION, AND A ¿SHOCKING OR JOLTING¿ SENSATION. THE PATIENT STATED THAT PREVIOUSLY THE STIMULATION WAS TOO LOW ON HER BODY NEAR THE VAGINA AND THE STIMULATION WAS TOO STRONG. AROUND THE TIME OF THE REPORT THE PATIENT WAS IN THE HEALTH CARE PROVIDER¿S (HCP) OFFICE AND WAS REPROGRAMMED AT ¿ABOUT 2.0 VOLTS BUT IT WAS STARTING TO HAPPEN AGAIN.¿ THE PATIENT STATED THAT DURING THE ¿WEEK AND A HALF¿ PRIOR TO THE REPORT SHE HAD BEEN GETTING A ¿JOLTING SENSATION, NOT ALL THE TIME JUST PERIODICALLY.¿ THE PATIENT REPORTED NO FALLS OR TRAUMAS AND HAD A HCP APPOINTMENT SCHEDULED FOR (B)(6) 2013. THE PATIENT WAS AFRAID TO SWITCH PROGRAMS BECAUSE SHE DID NOT KNOW WHAT EACH ONE DID. THE FOLLOWING DAY IT WAS REPORTED THAT THE PATIENT HAD ¿A LITTLE TROUBLE¿ WITH HER DEVICE, ALTHOUGH IT ¿SEEMED TO BE WORKING FAIRLY WELL.¿ THE PATIENT FELT ¿TREMENDOUS ELECTRICAL IMPULSES¿ NEAR HER VAGINA. THE PATIENT RECEIVED A NEW PROGRAMMER AND WAS REPROGRAMMED BY HER HCP ON (B)(6) 2013. THE PATIENT HAD A ¿FEW ACCIDENTS¿ BUT OVERALL THERAPY ¿SEEMED TO BE WORKING.¿ THE PATIENT STATED THAT SHE THOUGHT POSITIONAL CHANGES MAY HAVE BEEN RESPONSIBLE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236516 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1