BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3070139 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06616
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 2, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3 093-28 LOT# V620561, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FOUND IT WAS FURTHER REPORTED THE PATIENT FELT PULSING IN THE RIGHT BUTT AND IT WAS ¿UNCOMFORTABLE REAL SENSITIVE.¿ IT WAS NOTED THE PATIENT ¿COULD FEEL IT¿ WHEN SHE LAY ON HER BACK. IT WAS STATED THE PATIENT WAS IN GREAT PAIN. IT WAS REPORTED THE CALLER SAW ¿2 DEVICES WITH COM, WITH THE QUESTION MARK BETWEEN THEM.¿ IT WAS STATED THE PATIENT FELL THE WEEKEND PRIOR TO REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND HAD NO SYMPTOM CONTROL. THE PATIENT WAS FEELING STIMULATION IN THE DEVICE POCKET. IT WAS STATED THE PATIENT HAD STIMULATION UP TO 7.5V AND THEN MOVED, AND THEN RECEIVED A "JOLT." IN ADDITION TO THE SHOCKING/JOLTING REPORTED, IT WAS ALSO INDICATED THE STIMULATION WAS INTERMITTENT. THE STIMULATION WAS TURNED OFF AND THE "JOLTING"¿ WENT AWAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT PATIENT HAD LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD LOTS OF BLADDER PROBLEMS. SHE WAS GOING TO THE BATHROOM EVERY 2 HOURS AT NIGHT AND THEY ARE NOT SEEING ANY SYMPTOM RELIEF WITH THE NEUROSTIMULATOR (INS).THE REPORTER WAS UNSURE IF THE INS WAS ON OR IF PATIENT WAS FEELING STIM AND WOULD LIKE TO KNOW IF ADJUSTMENTS COULD BE DONE. SHE STATED SHE DID NOT REMEMBER IF THE TRIAL HELPED SHE FELT IT MAY HAVE BEEN A LITTLE BIT BUT SINCE IMPLANT OF INS PATIENT WAS NOT NOTICING ANY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171977 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1