BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6650217 · Received June 19, 2017

    Report

    Report Number
    3004209178-2017-13166
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Report Date
    June 19, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT# V233515, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT REPORTED VIA A MANUFACTURER REPRESENTATIVE (REP) THAT THERE WAS AN ELECTRODE ISSUE WHERE THE 0 ELECTRODE WAS READING GREATER THAN 4000 OHMS ON ALL COMBINATION INVOLVING 0. THE REP STATED THERE WAS NO KNOWN FACTORS. THE REP STATED THE PATIENT HAD AN IMPEDANCE CHECK ON (B)(6) 2017 AND THE ISSUE WAS DISCOVERED. THE REP STATED FOR TROUBLE SHOOTING THE PROGRAMMED AROUND THE 0 ELECTRODE AND THE PATIENT DESCRIBED ADEQUATE URINARY CONTROL. THE REP NOTED THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. THE REP STATED SURGICAL INTERVENTION DID NOT OCCUR AND WAS NOT PLANNED. THE PATIENT WAS LISTED AS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS NOTED THE PATIENT HAD A MEDICAL HISTORY OF AN OVERACTIVE BLADDER. THE PATIENT IS IMPLANTED FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430230 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1