BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2854633 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11062
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT # VA022Q8, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT FELT LIKE THE DEVICE 'DIDN'T WORK AT ALL' AND SHE STILL 'PEED THE BED AT NIGHT.' THE REPORTER STATED THAT ON (B)(6) 2012 THE PATIENT WAS AT THE PHARMACY WAITING AND SHE HAD TO GO TO THE BATHROOM SO SHE 'GOT OUT OF THERE AND WAS SOAKING WET.' IT WAS REPORTED THAT 'SOME DAYS WERE GOOD, SOME WERE BAD' FOR THE PATIENT. THE PATIENT INCREASED THE STIMULATION THE DAY BEFORE THE REPORT. IT WAS NOTED THAT THE PATIENT WAS GOING TO SEE THE MANUFACTURER REPRESENTATIVE 'NEXT MONTH.' ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS WORSENED. IT WAS STATED THAT THE PATIENT "NEVER HAD THERAPEUTIC EFFECT;" IT WAS FURTHER STATED THAT THE PATIENT WAS "SOAKED EVERY MORNING," HAD NO SYMPTOM CONTROL, AND SYMPTOMS WERE "WORSE THAN WHAT SHE WAS AT BEFORE IMPLANT." THE PATIENT REPORTEDLY DRANK "TOO MUCH" COFFEE AND DRANK "MORE NOW THAN SHE DID BEFORE," STATING THAT IT "MAY BE CONTRIBUTING TO HER SYMPTOMS." IT WAS NOTED THAT THE PATIENT "BACKED INTO A POLE AND THEN PHYSICALLY TRIED TO MOVE THE POLE" LESS THAN 24 HOURS AFTER IMPLANT. THE PATIENT REPORTEDLY SAW HER PHYSICIAN ON (B)(6) 2012, IN WHICH X-RAYS WERE TAKEN. IT WAS NOTED THAT THE PATIENT HAD OSTEOPOROSIS IN BACK AND HIP, WAS DIAGNOSED WITH CONGESTIVE HEART FAILURE, AND WAS ON LASIX. IT WAS FURTHER NOTED THAT THE PHYSICIAN AGREED THAT THE PATIENT LOWER HER LASIX DOSAGE. THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP APPOINTMENT ON (B)(6) 2012. IT WAS STATED THAT THE PATIENT SWITCHED PROGRAMS, AND WHEN SHE INCREASED UP TO 3 VOLTS, SHE COULD "FEEL IN THE PELVIC AREA" BUT IT "MAY BE TOO STRONG." TWENTY DAYS LATER, IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE "NEVER HAD THERAPEUTIC EFFECT," BUT STILL DRANK "WAY TOO MUCH COFFEE." IT WAS STATED THAT STIMULATION WAS ON, AND THE PATIENT SWITCHED PROGRAMS AND ADJUSTED STIMULATION. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    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