BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3041186 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04866
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 21, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA06FGT, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND THIS PERMANENT IMPLANT WAS DIFFERENT THAN HER TRIAL, WHICH WORKED TO RELIEVE URINARY AND BOWEL SYMPTOMS. THE PATIENT STATED IT FELT LIKE SHE WAS IN A PRE-IMPLANT STATE AND THAT ON THE DAY OF THE REPORT SHE HAD ALREADY HAD TWO PROBLEMS WITH INCONTINENCE. THE PATIENT ALSO STATED THAT SHE WAS GETTING "SHOCKS," LIKE BEING "ZAPPED." THIS HAPPENED MORE SO WHEN SHE MOVED AROUND. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY, BUT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE. TWO APPOINTMENT DATES OF (B)(6) WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142546 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR