BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3213342 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11492
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3 889-28 LOT# VA0334L, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. IMPEDANCES WERE NORMAL AND PROGRAM WAS CHANGED DUE TO VAGINAL PAIN. SYMPTOMS REPORTED INCLUDED FREQUENT, WATERY STOOLS, UP TO FIVE PER DAY, AND INCREASED GLUCOSE IN URINE. IT WAS STATED THE ISSUE WAS ONGOING AND THE PATIENT HAD A KNOWN HISTORY OF DIABETES AND WAS ON INSULIN PRIOR TO DEVICE IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT WAS IMPLANTED, SHE WAS DIAGNOSED AS A TYPE 1 DIABETIC. POST IMPLANT, THE PATIENT BEGAN HAVING URGENCY ISSUES AND BOWEL ISSUES. THE PATIENT WAS HAVING A BOWEL MOVEMENT 4-5 TIMES A DAY AND EXCESSIVE URINARY ACCIDENTS. SINCE HER IMPLANT HER BLOOD SUGAR READINGS IN HER URINE HAD BEEN VERY HIGH. THE PATIENT'S "A1C WAS REALLY HIGH" . THE PATIENT'S PRIMARY CARE PHYSICIAN HAD PRESCRIBED A LEVEMIR INSULIN PEN FOR TREATMENT. BEFORE THE LEVEMIR PEN, SHE WAS TAKING 2 PILLS A DAY TO TREAT DIABETES. THE PATIENT'S INTERSTIM DOCTOR INSTRUCTED HER TO TURN HER THERAPY OFF UNTIL THEY CAN FIGURE OUT WHAT IS HAPPENING WITH HER SYMPTOM. IT WAS NOTED THAT ALTHOUGH THE PATIENT HAD NOT USED HER PROGRAMMER, HER BATTERIES WERE ALMOST DEAD. THE PATIENT WAS ABLE TO TURN HER THERAPY OFF. THE LAST ADJUSTMENT THE PATIENT MADE WAS DONE ON (B)(6); THE PATIENT TURNED HER STIM FROM 1.3 TO 1.7. IT WAS NOTED THAT THE PATIENT SAW HER INTERSTIM DOCTOR TODAY ((B)(6) 2013) AND SHE WAS GOING TO CONTACT PRIMARY CARE PHYSICIAN TO LET HIM KNOW OF HIGH SUGAR LEVELS IN THE PATIENT'S URINE. IT WAS NOTED THAT DIABETES RUNS IN THE PATIENT'S FAMILY. THE DOCTOR WANTED THE PATIENT TO KEEP A JOURNAL OF BOWEL MOVEMENTS AND BATHROOM FREQUENCY AFTER STIM WAS TURNED OFF. THEY DID NOT WANT TO REMOVE DEVICE UNTIL THEY COULD DETERMINE WHAT THE CAUSE WAS OF HER SYMPTOMS. IT WAS NOTED THAT THE PATIENT'S PRIMARY CARE PHYSICIAN WAS NOT SUPPORTIVE OF INTERSTIM. IT WAS LATER REPORTED ON 2013 (B)(6) THAT THE PATIENT WAS HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE - APPT (B)(6) 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312812 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention