BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4532306 · Received February 20, 2015

    Report

    Report Number
    3004209178-2015-03435
    Event Type
    Injury
    Date Received
    February 20, 2015
    Report Date
    January 29, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V952333, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT STARTED TO HAVE SLOW LEAKAGE ABOUT A YEAR AFTER SHE WAS IMPLANTED WITH HER FIRST IMPLANTABLE NEUROSTIMULATOR (INS). SHE WAS GOING THROUGH PADS ¿LIKE CRAZY,¿ IT WASN¿T RIGHT, AND SHE WAS VERY UPSET. THE PATIENT NEVER HAD ANY RELIEF AND WAS DOING THE SAME AS SHE WAS BEFORE SHE EVER HAD THE DEVICE IMPLANTED. THIS HAD BEEN GOING ON FOR ABOUT A YEAR. THERE WAS A LOSS OF THERAPEUTIC EFFECT AND THE PATIENT STATED THAT SHE STARTED LEAKING ON (B)(6) 2014. THE PATIENT HAD BEEN BACK AND FORTH TO HER DOCTOR EVER SINCE AND DIDN¿T FEEL LIKE SHE WAS GETTING ANY ANSWERS. HER DOCTOR TRIED A ¿BLADDER SWING.¿ THE PATIENT¿S DOCTOR DECIDED TO CHANGE OUT THE INS ON (B)(6) 2014 AND SHE THOUGHT THIS WAS DUE TO BATTERY DEPLETION. THE BATTERY WAS NOT AT END OF SERVICE, BUT IT WAS ¿LOW FOR BEING IN FOR A YEAR.¿ THERE WAS AN IMPEDANCE READING WHEN IT WAS CHECKED ON THE DAY THE PATIENT CAME IN FOR A REPLACEMENT. THE DEVICE HAD BEEN IN CONTINUOUS MODE. THE PATIENT DIDN¿T KNOW WHAT THE SURGERY WAS FOR, ALL SHE KNEW WAS THAT THE DOCTOR SAID MAYBE THEY NEEDED TO CHECK THE DEVICE AND WIRES. THE PATIENT NEVER FOUND OUT THE RESULTS. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. SEE MFR. REPORT #3004209178-2015-03413 FOR INFORMATION REGARDING A NEW DEVICE THE PATIENT HAD AFTER THE SURGERY ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122224 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention