BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3240975 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12096
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 28, 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: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# VA012RA, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RETURN OF SYMPTOMS FOLLOWING A FALL 2-3 DAYS PRIOR TO THE REPORT. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT, NOTED AS 5 URINARY ACCIDENTS AND 2 BOWEL ACCIDENTS. THE PATIENT HAD SOME TESTS DONE, INCLUDING XRAYS. NOTHING WITH A MAGNET WAS PERFORMED. THE PATIENT HAD LOST HIS PROGRAMMER, AS HE DIDN¿T USE IT FREQUENTLY. THE PATIENT WAS TRYING TO LOCATE IT. IT WAS FURTHER REPORTED THAT A NEW PROGRAMMER AND RECHARGE ANTENNA WAS ORDERED FOR THE PATIENT. THE PATIENT AGAIN REPORTED A LOSS OF EFFECT, AS HE HAD AN ACCIDENT THE DAY OF THE REPORT. THE PATIENT WAS AFRAID TO LEAVE THE HOUSE. THE PATIENT NOTIFIED HIS PHYSICIAN AND HAD DECREASED HIS DIURETIC TO ½ TABLET IN THE EVENING. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340316 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR