BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3382115 · Received October 2, 2013

    Report

    Report Number
    3004209178-2013-17358
    Event Type
    Injury
    Date Received
    October 2, 2013
    Report Date
    September 10, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-28 LOT# V141757, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION. IT WAS ALSO STATED, THE PATIENT HAD PROBLEMS WITH THE ¿STIMULATOR AND STENTS¿ AND ¿POSSIBLY STENTS PULLED LOOSE OR MOVED¿ AND ¿SOMETHING WAS GOING ON WITH THE STIMULATOR, IT MALFUNCTIONED AND SHOCKED THE DEVIL OUT OF HER.¿ IT WAS NOTED THIS HAPPENED AFTER WALKING OUT INTO THE MALL, ¿THE OPENING¿ AFTER SHOPPING AT (B)(6). THE SHOCKED CAUSED SPASMS SO BAD AND IT MADE IT DIFFICULT TO WALK, AND HE COULDN¿T MOVE. THE PATIENT WAS NUMB ON THE LEFT SIDE/LEFT LEG AND THE MAJORITY OF THE TIME IT HURT WHEN HE WALKED. REPORTEDLY, THE PATIENT HURT EVER SINCE THAT HAPPENED. IT WAS ALSO NOTED, THE PATIENT WAS IMPLANTED FOR INTERSTITIAL CYSTITIS AND REPORTEDLY HAD 7-10 OPERATIONS/PROCEDURES FOLLOWING IMPLANT. THE PROCEDURES WERE FOR BLADDER EXTENSIONS WHERE THEY FILL MEDICINE IN A BALLOON FOR HIS BLADDER. THE PATIENT HAD AN APPOINTMENT WITH A PAIN SPECIALIST ON 2013 (B)(6). ADDITIONAL INFORMATION WAS REQUESTED BUT NOT KNOWN AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS STATED THERE WAS AN MRI/X-RAY/CT SCAN PLANNED FOR (B)(6) 2013. NO HOSPITALIZATION WAS NEEDED AND THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013. IT WAS ALSO STATED THE PATIENT HAD URINARY URGENCY, LEFT LEG PAIN, HYPERTENSION AND ABDOMINAL PAIN. THE PATIENT GOT UP TWO TIMES AT NIGHT TO URINATE. IT WAS NOTED THE SURGICAL INCISIONS WERE WELL HEALED, URINE ACIDITY WAS 5.0 AND SPECIFIC GRAVITY WAS 1.020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497514 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention