BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6224107 · Received January 4, 2017

    Report

    Report Number
    3004209178-2017-00249
    Event Type
    Malfunction
    Date Received
    January 4, 2017
    Report Date
    February 16, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REPORTED SEEING A CONSUMER FOR REVIEW AND THE DEVICE HAD BATTERY LIFE OF 4-5 MONTHS WITH A CAPACITY OF 86%-100%, WHICH DID NOT SEEM CONSISTENT. THE CONSUMER WAS IMPLANTED IN (B)(6) 2015. IT WAS NOTED THAT CYCLING WAS NOT USED. PROGRAMMING WAS C+2- AT 1.7 V SINCE (B)(6) 2016. THE CONSUMER WAS SEEN ON (B)(6) 2016 AND PROGRAMMING CHANGED TO 0+3- AS EFFICACY HAD DECREASED; THE CONSUMER FELT IN SADDLE. NO PROBLEM WITH THE LEAD IMPEDANCE AT THIS VISIT; HOWEVER, IT WAS NOTED THAT BACK IN (B)(6) 0+1- <(> <<)>50, BUT NOTHING ELSE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE REPORTED THAT THE NURSE INDICATED THAT TREATMENT WAS WORKING WELL. LEAD IMPEDANCE WAS CHECKED AMP 2 PW 300, AND BATTERY LIFE SHOWED 63-74 MONTHS OF SERVICE REMAINING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE REPORTED THE CONSUMER¿S RELEVANT MEDICAL HISTORY TO INCLUDE PREVIOUS SPINAL SURGERY. THE REPRESENTATIVE WOULD BE BRINGING THE CONSUMER BACK UP TO CLINIC TO CARRY OUT THE CHECKS, AND NOTED TO HAVE LISTED THE CONSUMER FOR A CHANGE OF IMPLANT IN THE MEANTIME, AS THE WAITING LIST IS FOUR (4) MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5308 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1