BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3256467 · Received July 31, 2013

    Report

    Report Number
    3004209178-2013-12557
    Event Type
    Injury
    Date Received
    July 31, 2013
    Report Date
    July 8, 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

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-33, LOT # V863545, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPERIENCE WITH THIS IMPLANT WAS ¿TERRIBLE.¿ THE PATIENT REPORTEDLY GOT AN INFECTION AND IT HURT HER SO MUCH. THIS ¿PUT THE PATIENT IN A BAD PLACE.¿ NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED AND THERE WAS NO INFECTION REPORTED. IT WAS STATED THE PATIENT DID NOT HAVE PAIN, BUT COMPLAINED THE VAGINAL SENSATIONS WERE UNPLEASANT. IT WAS ALSO STATED THE PATIENT EXPERIENCED MIDLINE CYSTOCELE, FEMALE STRESS INCONTINENCE, MORBID OBESITY, RECTOCELE, AND URGE INCONTINENCE. IT WAS NOTED THE PATIENT WAS HAVING UNWANTED VAGINAL AND BLADDER SENSATIONS AND WANTED THE DEVICE REMOVED, WHICH WAS TENTATIVELY SCHEDULED FOR (B)(6) 2012. THE PATIENT TRIED MULTIPLE PROGRAMS BUT WAS UNHAPPY WITH THE RESULTS. SHE HAD MANY VAGINAL COMPLAINTS, AND MIXED URINARY INCONTINENCE. REPORTEDLY THE PATIENT HAD THE DEVICE REMOVED AND STATED SHE WAS LEAKING MORE SINCE THE IMPLANT WAS REMOVED. SHE ALSO LEAKED AT TIMES WITH COUGHING AND SNEEZING. THERE WAS NO SIGN OF INFECTION AND THE WOUND WAS HEALING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356981 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention