BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4274606 · Received November 24, 2014

    Report

    Report Number
    3004209178-2014-22128
    Event Type
    Injury
    Date Received
    November 24, 2014
    Report Date
    October 30, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V802377, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# V802377, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFECT SIX MONTHS PRIOR TO THE NEUROSTIMULATOR (INS) REPLACEMENT. THE PATIENT URINATED EVERY COUPLE OF HOURS WHEN THE DEVICE WAS WORKING BUT WHEN THE INS BATTERY DEPLETED THAT PATIENT WAS IN AND OUT OF THE BATHROOM EVERY 20-30 MINUTES GETTING UP TO GO TO THE BATHROOM AT NIGHT ALSO. IT WAS NOTED THAT WHEN PATIENT HAD THE URGE TO GO HE HAD TO GO RIGHT AWAY. THE PATIENT TURNED UP THE SETTINGS BUT IT DID NOT MAKE A DIFFERENCE. IT WAS NOTED THAT PATIENT¿S WIFE MENTIONED SOMETHING WAS WRONG. THEY TESTED THE INS BATTERY AND IT WAS DEPLETED. THE HEALTH CARE PROVIDER TOLD THE PATIENT THE BATTERY WOULD LAST 5 YEARS BUT IT ONLY LASTED 3 YEARS. THE REPORTER WAS NOT SURE IF THE SETTING WAS LOWER OR HIGHER. THE REPORTER STATED THAT THE PATIENT WAS SEEN 3 TIMES BY THAT REPRESENTATIVE AND WAS TOLD THAT THE ISSUE WAS THE INS BATTERY. PATIENT THOUGHT IT WAS JUST THE BATTERY THAT WAS REPLACED. THE HEALTH CARE PROVIDER STATED EVERYTHING WAS PERFECT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760924 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention