BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3233713 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11963
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 24, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# VA08A6V, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT# VA08A6V, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TURNED STIMULATION UP FROM 3.2V TO 3.3V AND FELT A JOLT LIKE IT DID WHEN SHE WAS WOKEN UP FROM SURGERY TO MAKE SURE ¿A CERTAIN SPOT WAS FOUND.¿ THE PATIENT HAD SYMPTOMS OF HIGH BLOOD PRESSURE, ¿BLUE MOUTH¿, BLADDER SPASMS, NOSE BLEEDING, URINARY RETENTION AND A PULSE THAT WAS ¿THROUGH THE ROOF.¿ THE RETENTION HAD REPORTEDLY BEEN CONSTANT FOR THE 3 DAYS PRIOR TO THE REPORT, BUT HAD BEEN ¿ON AND OFF¿ SINCE SURGERY. THE PATIENT ALSO EXPERIENCED TREMENDOUS PAIN FROM THE REPLACEMENT SURGERY SHE HAD. THE REPORTER STATED THAT THE PATIENT WAS ASSURED THAT THE LEAD WAS ATTACHED WELL THIS TIME. AT THE TIME OF THE REPORT, STIMULATION AMPLITUDE WAS AT 2.3V AND IT ¿HURT SO BAD.¿ THE PATIENT WAS ALSO FEELING EXTREMELY NAUSEATED AND HER HEART RATE WAS HIGH. THE REPORTER STATED THAT THE PATIENT THOUGHT SHE WOULD BE ADMITTED TO THE EMERGENCY ROOM (ER). THE PATIENT¿S BLADDER AND BACK WHERE THE LEAD INCISION WAS, WERE ¿SPASMING SO BAD.¿ THE PATIENT¿S NURSE COULD REPORTEDLY SEE THE SPASMS ABOVE THE PATIENT¿S ABDOMEN. NOW THAT STIMULATION HAD BEEN TURNED OFF, IT JUST FELT SORE. THE PATIENT WAS NOT FEELING THE THRILL ANYMORE. IT WAS NOTED THAT THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA. IT WAS LATER REPORTED THAT THE PATIENT¿S SYMPTOMS OF HIGH BLOOD PRESSURE, BLUE MOUTH AND RETENTION WERE NOT DUE TO THE DEVICE. THE PATIENT HAD BEEN INSTRUCTED BY HER HEALTHCARE PROVIDER (HCP) TO GO TO THE ER FOR EVALUATION OF HER RETENTION. THE PATIENT ATTEMPTED TO CHANGE THE SETTING ON HER DEVICE TO HELP WITH THE RETENTION AS SHE THOUGHT MORE STIMULATION WOULD HELP. SHE SUBSEQUENTLY TURNED STIMULATION UP TOO HIGH AND THAT¿S WHEN SHE SHOCKED HERSELF. THE PATIENT HAD BEEN INSTRUCTED TO TURN STIMULATION TO ZERO AND INCREASING STIMULATION FROM THAT POINT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEING A WARNING SCREEN WITH A CIRCLE AND A ¿C¿ IN IT. THREE DAYS LATER, IT WAS REPORTED THAT THE PATIENT DIDN¿T GO TO THE ER AFTER THE REFERRAL BY HER HCP. THE PATIENT THOUGHT HER ISSUES WERE DUE TO RETENTION. THE PATIENT TURNED THE IMPLANTABLE NEUROSTIMULATOR (INS) BACK ON AND WAS DOING WELL. NO INTERVENTIONS HAD BEEN PLANNED. REFER TO MANUFACTURER'S REPORT # 3004209178-2013-11243 FOR INFORMATION PERTAINING TO THE PATIENT'S PREVIOUS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334999 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1