BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4024373 · Received August 20, 2014

    Report

    Report Number
    3004209178-2014-15598
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V001988, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PROGRAMMER SHUTS OFF COMPUTER SYSTEMS AND SHUTS PACEMAKERS OFF. THE PATIENT HAD BEEN TOLD TO KEEP THE BATTERIES OUT OF IT WHEN GOING INTO HOSPITAL SETTINGS AND THAT SORT OF THING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. THE PATIENT HAD AN APPOINTMENT ON 2014-(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501416 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1