BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3120948 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07948
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 29, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3889-28, LOT# V006693, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS STATED THAT THE PATIENT WOULD GET A ¿ZAP¿ IN THE SPHINCTER AREA WHEN THEY WOULD LAY ON THEIR BACK OVER THE PAST YEAR. IT WAS DESCRIBED AS PAINFUL. IT WAS NOTED THE PATIENT HAD ¿TRAINED¿ HERSELF NOT TO SLEEP ¿THAT WAY¿ SO IT WOULD NOT HAPPEN. IT WAS ADDED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD NOTICED SYMPTOM RETURN OVER THE PAST SIX MONTHS AND HAS NEEDED TO USE CATHETERS AGAIN. THE PATIENT COULD STILL FEEL STIMULATION, BUT IT ¿CAME AND WENT.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    AFTER FURTHER REVIEW, IT WAS REPORTED THAT THE PATIENT THINKS THE BATTERY WAS LOW BECAUSE IT WAS "NOT WORKING RIGHT". IT WAS NOTED THAT THE PATIENT SYMPTOMS HAD "GOTTEN QUITE TERRIBLY WORST IN THE LAST THREE MONTHS". IT WAS ALSO REPORTED THAT A FEW TIMES THE PATIENT WOULD WAKE UP WITH SOME PRETTY EXTREME PAIN IN THE MIDDLE OF THE NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222444 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR