BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3132898 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08245
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    January 11, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3080, LOT # L80927, IMPLANTED: (B)(6) 2000, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    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

    IT WAS REPORTED THAT IMPEDANCES WERE GREATER THAN 4,000 OHMS FOR ¿LEAD 0.¿ THE PATIENT WAS REPROGRAMMED AROUND ¿LEAD 0¿ ON (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE REPORTED THE LEAD AND EXTENSION WERE ALSO MODIFIED FOR NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT LEAD 0 REMAINED NON-FUNCTIONAL AND STILL HAD IMPEDANCES GREATER THAN 4,000 OHMS. LEAD 0 WAS BROKEN PER IMPEDANCES. THEY PROGRAMMED AROUND IT AND THE SYMPTOMS WERE WELL CONTROLLED. THE LEAD WAS GOING TO BE REPLACED AT THE NEXT BATTERY CHANGE. THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236528 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR