BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3061389 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06347
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    February 27, 2018
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V061745, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE PRODUCT ID 3889-28 LOT# V061745 IMPLANTED: (B)(6)2007 PRODUCT TYPE LEAD PRODUCT ID 3037 SERIAL(B)(4) IMPLANTED: (B)(6)2007 IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR PHYSICIAN AND MANUFACTURER¿S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED (AN APPOINTMENT OF (B)(6) 2013 WAS NOTED). THE PATIENT ALSO REPORTED THAT THEY STILL HAD CONCERNS REGARDING THEIR DEVICE THERAPY BUT WAS WORKING WITH THEIR DOCTOR AND MANUFACTURER¿S REPRESENTATIVE TO RESOLVE THE ISSUE. AN APPOINTMENT OF (B)(6) 2013 WAS NOTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S STIMULATOR WAS REMOVED. THE PATIENT'S THERAPY HELPED FOR ONE YEAR, BUT THEN THEY STARTED WETTING THEMSELVES. IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL PAIN AND SHOCKING. STIMULATION WAS TURNED OFF AND THE PATIENT WAS PRESCRIBED VESICARE. IN (B)(6) 2015, THE PATIENT EXPERIENCED BUTTOCKS AND LEFT HIP PAIN. THE PATIENT STILL HAD MUSCLE AND JOINT PROBLEMS FOLLOWING THE EXPLANT. THEY HAD BEEN DIAGNOSED WITH FIBROMYALGIA AND SCIATICA. THE PATIENT DID NOT CURRENTLY HAVE AN INFECTION, BUT THEIR URINE SMELLED BAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S THERAPY HAD CAUSED NOTHING BUT PROBLEMS. THEIR THIGH MUSCLE BOTHERED THEM. THE PATIENT WAS TAKING PAIN MEDICATION. THE PAIN WAS SO GREAT THEY COULD NOT SLEEP. THEY WERE ALSO GIVEN SLEEP MEDICATION. THE PATIENT'S PAIN ROSE UP AND BROUGHT THEM TO THEIR KNEES. THEY THEN LAY ON THE COUCH FOR THREE DAYS. THE PATIENT WENT TO THEIR HEALTHCARE PROVIDER FOR SCIATICA PROBLEMS, BUT AN X-RAY SHOWED NOTHING WAS WRONG. LATER, THE PATIENT HAD KNOTS ALL OVER THEIR BODY. THE PATIENT TESTED NEGATIVE FOR LUPUS AND RHEUMATOID ARTHRITIS. THE PATIENT HAD GONE TO THE HOSPITAL THREE TIMES FOR THE PAIN AND PAIN SHOTS. WHEN THEIR HEALTHCARE PROVIDER CHECKED THEIR STIMULATOR, THE PATIENT GOT ZAPPED REALLY HARD. ONE OF THE LEADS WAS PROBABLY MESSED UP. THE STIMULATOR WAS TURNED OFF. THE PATIENT'S PAIN WAS BETTER THE NEXT DAY. A WEEK LATER, AFTER VISITING A CHIROPRACTOR, MOST OF THEIR KNOTS HAD GONE AWAY. STIMULATION HAD DESTROYED THE PATIENT'S LEG MUSCLE AND WANTED THE SYSTEM REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BLADDER INFECTION FOR A LONG TIME EVEN BEFORE THE IMPLANT. A COUPLE MONTHS AGO BLADDER INFECTION WENT CLEARED UP. THE PATIENT HAD ARTHRITIS AND COMPRESSION FRACTURE IN THE BACK AND WAS TREATED FOR OSTEOPOROSIS. THE PATIENT HAD BACK AND HIP PROBLEMS BUT WAS SEEING A CHIROPRACTOR. THE PATIENT HAD 50% RELIEF IN SYMPTOMS. THE PATIENT WAS CONFUSED ABOUT THERAPY BUT THINKS SHE GOT IT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WITH PATIENT REPORTING THAT THE INS WAS REMOVED DUE TO IT BEING BROKEN; FURTHER BEING CLARIFIED AS IT WAS REMOVED BECAUSE PATIENT WAS HAVING TROUBLE GETTING SHOCKED. THEY AGAIN STATED THAT THE HEALTHCARE PROFESSIONAL (HCP) TURNED INS OFF AND THEN WHEN THEY TURNED IT BACK ON, PATIENT GOT SHOCKED MAKING THEM JUMP OFF THE TABLE. HCP TOLD PATIENT INS NEEDED TO BE REMOVED SO IT WAS TAKEN OUT. DURING THE REMOVAL, THE HCP NOTICED THAT THE WIRE BROKE OFF AND WAS WRAPPED AROUND THE PATIENT'S NERVE. PATIENT HAD TO STAY UNDER AND STAY OVERNIGHT IN THE HOSPITAL BECAUSE NEUROSURGEON (B)(6) HAD TO ASSIST HCP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REVIEWED INDICATED THAT PATIENT WAS IN A LOT OF PAIN AND SO THEY BEEN USING THE TENS UNIT. I ALSO INDICATED THAT THEY HAVE BEEN USING DIATHERMY TREATMENT 2 AND HALF WEEKS PRIOR TO THIS REPORT. IT WAS FURTHER REPORTED THAT THE INFECTION PROBLEM JUST KEPT GETTING WORSE, YOU KNOW, BUT WAS CLEARED UP NOW. IT WAS ADDED THAT PATIENT STARTED HAVING SOME BLADDER PROBLEMS, YOU KNOW, WITH INFECTIONS AND STUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162524 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention