BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1525890 · Received November 6, 2009

    Report

    Report Number
    3004209178-2009-08776
    Event Type
    Injury
    Date Received
    November 6, 2009
    Date of Event
    October 23, 2009
    Report Date
    October 27, 2009
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NOT PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS, AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# V111324, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS SENT TO HIS DOCTOR'S OFFICE DUE TO HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE READING WAS OVER 600 MG/DL AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME AND SELF TESTS PASSED. NOTHING FURTHER WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE PATIENT HAD DEMENTIA AND HAD NOT USED THE DEVICE "IN A WHILE" BECAUSE THEY WERE UNABLE TO WORK IT. NOW THAT THE PATIENT WAS IN ASSISTED LIVING, THE PATIENT COULD RECEIVE ASSISTANCE ON USING THE DEVICE. IT WAS NOT KNOWN IF THERE WERE ISSUES WITH THE DEVICE, BUT THE PATIENT WAS HAVING INCONTINENCE AGAIN. THE CONSUMER WAS UNSURE IF THE INCONTINENCE WAS A PROBLEM OR IF IT WAS THE DEMENTIA. AN APPOINTMENT WAS SCHEDULED TO MEET WITH THE HEALTHCARE PROVIDER (HCP). THE PATIENT WAS INDICATED FOR INTERSTIM- OTHER AND BOWEL DYSFUNCTION IN ADDITION FOR PREVIOUSLY REPORTED HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE LZG MEDTRONIC MED REL MEDTRONIC PUERTO RICO MMT-522WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention