BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3843947 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09985
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 12, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3093-28, LOT# V962975, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V846375, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD 2 BLADDER IMPLANTS, ONE WAS 2 YEARS OLD AND THE OTHER WAS 1 YEAR OLD. IT WAS NOTED THAT THIS PAST MARCH THE PATIENT RECEIVED A SPINAL CORD STIMULATION (SCS) SYSTEM. FOR THE FIRST MONTH EVERYTHING WORKED FINE AND THE PATIENT COULD EMPTY THEIR BLADDER HOWEVER FOR THE PAST MONTH THEY HAD NOTICED THAT WHEN THEY INCREASED THE SCS SYSTEM THEY HAD BEEN HAVING A MORE DIFFICULT TIME URINATING. IT WAS REPORTED THAT THE PATIENT HAD TRIED CHANGING THE DIFFERENT SYSTEMS AND THEY TURNED THE LEFT BLADDER UNIT OFF ONCE AND COULDN¿T URINATE AT ALL, THEN THEY TURNED THE RIGHT BLADDER UNIT OFF AND THAT DIDN¿T WORK EITHER. THE PATIENT EVEN TRIED ADJUSTING HALF AND HALF AND ALSO TURNED THE SCS UNIT OFF. IT WAS NOTED THAT THE PATIENT HAD THE SCS UNIT PLACED IN THE MIDDLE OF THEIR LOWER BACK AND THE BLADDER SYSTEMS WERE ON EACH SIDE. BOTH HEALTH CARE PROVIDERS (HCPS) WERE AWARE THAT THE PATIENT HAD THE OTHER SYSTEM. IT WAS REPORTED THAT THE PATIENT HAD THE SCS SYSTEM TWEAKED AS WHEN IT WAS ON AUTO-PROGRAM THEY DIDN¿T LIKE IT AND THEN THEY PROGRAMMED BACK TO 1. WHEN THE PATIENT HAD 2 PROGRAMS THEY COULDN¿T URINATE BUT WHEN THEY ONLY HAD 1 THEY COULD URINATE. IT WAS NOTED THAT THE PATIENT WAS WONDERING IF THEY COULD BE OVERSTIMULATING OR UNDERSTIMULATING THEIR BLADDER NERVES. THE PATIENT DID NOT KNOW IF THEY HAD A URINARY TRACT INFECTION (UTI) BUT MENTIONED FREQUENCY AND INQUIRED ABOUT IF A YEAST INFECTION OR CONSTIPATION COULD AFFECT URINATION. REFER TO MANUFACTURER REPORT # 3004209178-2014-09984.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEFT SIDE REVISION AND DID NOT KNOW IF THE LEFT LEAD OR LEFT IMPLANTABLE NEUROSTIMULATOR (INS) WAS REVISED. THE PATIENT DID NOT KNOW THE DATE OF THAT EVENT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. REFER TO MANUFACTURER¿S REPORT # 3004209178-2014-18432 FOR THE PATIENT¿S PREVIOUS RIGHT LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321450 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention