BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2911121 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-00484
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V807714, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING SOME TESTS RUN TO DETERMINE WHY HER PULSE WAS SO LOW. THE PATIENT HAD REPORTEDLY HAD A "VERY LOW PULSE" OF BETWEEN 40 TO 42 BEATS PER SECOND IN THE LAST COUPLE OF MONTHS AS OPPOSED TO 60 TO 69 BEATS PER SECOND, WHICH WAS IT WAS SUPPOSED TO BE. THE REPORTER INDICATED THAT TESTING HAD BEEN DONE FOR OVER TWO MONTHS, INCLUDING HAVING A CT SCAN, CARDIO, AND EKG DONE, BUT THERE WAS NO EXPLANATION FOR WHAT WAS HAPPENING. THERE WAS NO PROBLEM WITH THE HEART VENT OR ARTERY EXCEPT THAT "THE RHYTHM WAS OFF". IT WAS NOTED THAT WHEN THE PATIENT DID A LITTLE ACTIVITY, THE PULSE WENT UP A LITTLE BIT AND ABOUT 30 MINUTES LATER, WENT "BACK DOWN TO A STRAIGHT LINE". THE PATIENT WAS GETTING VERY TIRED WHEN WALKING AND WAS "GASPING FOR BREATH". THE REPORTER INDICATED THAT THE PATIENT THOUGHT, SHE MIGHT NEED A PACEMAKER FOR THE HEART. THE PATIENT ALSO WANTED TO TURN THE DEVICE OFF FOR A WEEK, HAVE MORE TESTS DONE AND MONITOR SYMPTOMS. THE REPORTER STATED THAT THIS PROBLEM WAS DEVICE RELATED BECAUSE, THE PATIENT'S HEALTHCARE PROVIDER (HCP) THOUGHT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS "TRANSMITTING SIGNALS TO THE BRAIN AND COULD BE CONTRIBUTING TO THE LOW PULSE". THE REPORTER STATED THAT AFTER THE TESTS HAD BEEN COMPLETED, AND THEY SHOWED THAT THE INS WAS NOT RESPONSIBLE FOR THE LOW PULSE, IT MAY STILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18426 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other