BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2988243 · Received March 4, 2013

    Report

    Report Number
    3004209178-2013-03282
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Report Date
    February 15, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V896802, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE HAD 'WORKED FOR THE FIRST 5-6 MONTHS.' THE PATIENT "KEPT INCREASING IT" AND IT WOULD NOT HELP AS SHE WAS GOING TO THE BATHROOM ON HERSELF STARTING IN (B)(6) 2012. IT BEGAN WORKING AGAIN AT UNSPECIFIED DATE, AND THEN STOPPED ON (B)(6) 2012. IT WAS REPORTED THE PATIENT HAD TO INCREASE SETTINGS ON (B)(6) 2012. SINCE THEN, IT WAS REPORTED AS PAINFUL AND IRRITATING, ESPECIALLY WHEN THE PATIENT WOULD GO TO BED. FIVE DAYS PRIOR TO THE DATE OF REPORT, THE PATIENT WAS IN BED AND HAD PAIN WHEN SHE TRIED TO GET UP. THE PAIN WAS AROUND THE IMPLANT AND BOTH KIDNEYS. IT WAS NOTED AS OCCURRING WHEN THE PATIENT GOT UP IN THE MORNING OR WENT TO BED. THE PAIN WAS REPORTED TO RADIATE TO THE FRONT OF THE PATIENT. THE PATIENT TURNED THE DEVICE OFF THE DAY PRIOR TO REPORT, AND THE PAIN STOPPED. IT WAS NOTED THAT THE PATIENT DID NOT RECEIVE PROPER INSTRUCTION AFTER IMPLANT OR SINCE. THE PATIENT WAS TO SEE HER HEALTH CARE PROVIDER PRIOR TO TURNING THE DEVICE BACK ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91084 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1