BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3971760 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13789
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V001759, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE THAT A COMPATIBILITY GUIDELINES WERE REQUESTED FOR MRI. THE MRI TECH NOTED THAT INS (STIMULATOR) NO LONGER WORKING. SPOKE WITH THE PATIENT REGARDING INS, AND SHE NOTED THE BATTERY DIED. PATIENT WAS NOT SURPRISED THE INS BATTERY DIED AND WAS TOLD BY MANAGING HCP (HEALTHCARE PROVIDER) THAT IT WOULD DIE (JUST LIKE THE PREVIOUS ONE). PATIENT NOTED A KNEE SURGERY THAT OCCURRED IN (B)(6) 2013. PATIENT NOTED UNABLE TO TURN OFF INS. THE STIMULATOR WAS NOTED AS WASN'T WORKING. PATIENT INDICATED A MANUFACTURER REPRESENTATIVE WAS PRESENT AND COULDN'T FIGURE IT OUT EITHER. THINK THE PATIENT WAS REFERRING TO PATIENT PROGRAMMER AND INS COMMUNICATION. PATIENT WAS UNSURE WHEN INS STOPPED WORKING. PATIENT ALSO ALLUDED TO THE MANUFACTURER REPRESENTATIVE WAS SUPPOSED TO CALL HER BACK AFTER SPEAKING WITH SOMEONE ELSE REGARDING HER COMMUNICATION ISSUE BUT SHE NEVER HEARD BACK FROM ANYONE. ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT WAS NOT THERE FOR A MRI DUE TO DEVICE SO THEY HAVE NO OTHER INFORMATION ON WHO THEIR HCP (HEALTHCARE PROVIDER) WOULD BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447296 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1