BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3172803 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10445
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PRODUCT ID: 3889-28, LOT# VA02QA8, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING TROUBLE GETTING THE PATIENT PROGRAMMER SCREEN ON. REVIEW OF APPLICABLE BATTERY CONSIDERATIONS RESOLVED THE ISSUE. IT WAS REPORTED THAT THE PATIENT THOUGHT THE DEVICE WAS NOT HELPING AS MUCH AS SHE THOUGHT IT WOULD. THE PATIENT WENT TO THE BATHROOM TWICE LAST NIGHT AND TWO TIMES THIS MORNING. BEFORE IMPLANT, THE PATIENT WAS GOING TO THE BATHROOM FOUR TO FIVE TIMES A NIGHT. THE PATIENT NEVER THOUGHT IT WAS AS GOOD AS IT WAS SUPPOSED TO BE. IT WAS NOTED THAT THE PATIENT¿S TRIAL WAS GOOD, BUT SHE WAS EXPECTING BETTER FROM THE IMPLANT AND HAD HIGH EXPECTATIONS. THE PATIENT WAS ON PROGRAM 3 AT 1.4 V, WHICH WAS RECENTLY CHANGED THERE BY THE PATIENT¿S PHYSICIAN. THE PROGRAM WAS SWITCHED TO PROGRAM 4 AT 1.1V AND WAS GOING TO TRY THAT SETTING AND SEE HOW IT WORKED FOR THE PATIENT. FOLLOW-UP INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT AS THE PATIENT HAD MODERATE CYSTOCELE CAUSING INCREASE IN SYMPTOMS. IT WAS NOTED THAT A PESSARY WAS PLACED A WEEK AGO. IT WAS NOTED THAT THE PATIENT HAD NOT TRIED ALL PROGRAMMING OPTIONS AVAILABLE TO HER, THE PESSARY WAS PLACED FOR BLADDER SUPPORT, THE PATIENT WAS TO FOLLOW-UP WITH THE PHYSICIAN AND MAY TRY ADDITIONAL PROGRAMS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS HAVING TROUBLE WITH THEIR PROGRAMMER. THEY WERE GETTING AN UPPER LIMIT SCREEN AT 4.9. THE BATTERIES WERE REPLACED A MONTH PRIOR TO THE REPORT AND THEY LOOKED GOOD ON THE PATIENT PROGRAMMER ICON. THE PATIENT WAS ON PROGRAM 2 AT 3.1V AND THEY WERE FEELING THE TAPPING. SINCE THE IMPLANT THE PATIENT HAD BEEN HAVING SYMPTOMS AT NIGHT AND THEY WOULD FILL UP THE PAD. THE PATIENT ALSO HAD SYMPTOMS DURING THE DAY AND SOMETIMES THEY WOULD HAVE URGENCY TO GO AND WOULDN'T MAKE IT TO THE BATHROOM ON TIME. THE PATIENT'S DOCTOR WAS AWARE OF THE SYMPTOMS AND TOLD THE PATIENT TO KEEP TRYING. THE PATIENT WAS HAVING A LOSS OF THERAPEUTIC EFFECT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273198 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention