BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2602350 · Received June 7, 2012

    Report

    Report Number
    3004209178-2012-04134
    Event Type
    Injury
    Date Received
    June 7, 2012
    Report Date
    May 9, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT# V801866, IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYP PROGRAMMER, PATIENT. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED RIGHT AFTER IMPLANT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS POSITIONED TOO LOW IN HER BODY. THE PATIENT FELT STIMULATION IN FRONT BUT WOULD HAVE TO SIT ON A PILLOW BECAUSE OF THE INS POSITION. IT WAS STATED ABOUT 1-2 MONTHS AFTER IMPLANT THE DOCTOR MOVED THE INS TO A HIGHER POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BOWEL ISSUES, CONSTIPATION AND "GAS ISSUES" SINCE IMPLANT OF THE NEUROSTIMULATOR. PRIOR TO IMPLANT, THE PATIENT EXPERIENCED DIARRHEA DUE TO CELIAC DISEASE. THE PATIENT ALSO REPORTED PAIN AROUND THE INS AND LEAD LOCATION ON THE LEFT SIDE. THE PATIENT REPORTED PAIN LAYING DOWN, IN A SITTING POSITION, OR IF ANYTHING TOUCHED THE IMPLANT SITE. THERE WERE NO FALLS OR TRAUMA REPORTED. THERE WAS NO SWELLING OR REDNESS IN THE IMPLANT AREA. THE PATIENT REPORTED THERE WAS NO NOTICEABLE WEIGHT LOSS OR GAIN AND THAT THE IMPLANT FELT DEEPER THAN BEFORE. THE THERAPY WAS WORKING FINE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE WAS NORMAL POST-OP PAIN. THERE WERE NO KNOWN ABNORMAL IMPEDANCE MEASUREMENTS. A REVISION WAS PERFORMED (B)(6) 2012. THE DEVICE WAS MOVED SECONDARY TO A 25 POUND WEIGHT LOSS. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS THE MOST UNCOMFORTABLE THING THE PATIENT HAD EVER ENDURED. THE PATIENT HAD TO PUT A PILLOW ON THEIR SIDE AT NIGHT. THE DEVICE HAD BEEN UNCOMFORTABLE SINCE THE DEVICE WAS PUT IN AND IT HAD GOTTEN WORSE. WHEN THE PATIENT BENT OVER IT WAS STINGING. THE PATIENT DIDN'T HAVE A CURRENT HEALTH CARE PROVIDER (HCP).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention