BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3930142 · Received July 11, 2014

    Report

    Report Number
    3004209178-2014-12926
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 5, 2014
    Report Date
    September 15, 2014
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-28, LOT# VA01R8D, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-28, LOT# VA01R8D, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER INDICATING THAT THE FIRST NEUROSTIMULATOR (INS) WAS WORKING FINE BUT AFTER WHILE IT STOPPED WORKING, AFTER 2 YEARS. THE PATIENT INDICATED THAT WITH THE FIRST INS SHE WAS PEEING ON HER OWN OR LESS BUT STILL HAD SOME RETENTION. IT WAS INDICATED THAT THE REASON FOR REPLACEMENT WAS DUE TO BROKEN WIRE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS SOMETHING WRONG WITH THE WIRE ON THE PATIENT'S FIRST IMPLANTABLE NEUROSTIMULATOR (INS). THEY TESTED IT AND IT WAS NOT ACTIVE. THE FIRST INS IMMEDIATELY STARTED TO WORK, BUT NOT FULLY AND THE PATIENT FOUND OUT BECAUSE THEY STILL HAD TO CATHETERIZE. THE PATIENT WASN'T CATHETERIZING BECAUSE THEY WENT 16 OR 20 OZ SO THEY DIDN'T THINK THEY HAD TO CATHETERIZE. IT TURNED OUT THEY SHOULD HAVE BEEN CATHETERIZING AT LEAST ONCE A DAY BECAUSE THEY STILL HAD RETENTION. THEY HAD USED ANESTHESIA FOR BOTH PROCEDURES. THE FIRST MANUFACTURER REPRESENTATIVE SET THE FIRST INS AT 0.3V AND THE PATIENT NEVER HAD TO CHANGE IT BECAUSE THEY WERE PEEING ON THEIR OWN AND DIDN'T HAVE TO CATHETERIZE. THEY DID A LOT OF TESTING AND IT WAS VERY ACTIVE. WHEN THE PATIENT WENT IN TO SEE THEIR HEALTH CARE PROVIDER (HCP) AFTER 2 WEEKS, THEY ASKED IF THE PATIENT FELT ANYTHING AND THEY SAID NO. FOR THE FIRST INS THE PATIENT HAD THE SETTING WRITTEN DOWN AS 0.1 ON THE LEFT AND 3.0. THE PATIENT DID NOT REMEMBER STIMULATION BEING IN VAGINAL AND RECTAL AREA WITH THE FIRST INS FOR RETENTION. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER NOTED THAT THE REASON FOR THE REPLACEMENT WAS THAT SOMETHING WAS WRONG WITH THE WIRE AND THERE WAS NO CONNECTION AND TH OUGHT HER NEUROSTIMULATOR (INS) WAS REPLACED ALSO. THE PATIENT STATED THAT WITH HER FIRST NEUROSTIMULATOR (INS) SHE HAD BEEN CATHETERIZING IN THE EVENING WAS STILL RETAINING AND WAS ABLE TO GET BY DURING THE DAY AND COULD PEE IN BETWEEN ROUNDS OF GOLF. THE PATIENT NEVER HAD TO ADJUST THE FIRST INS AT ALL AND SOMETIMES LATER ON SOMETHING HAPPENED TO THE WIRE AND HAD TO GET A NEW ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WENT IN FOR A CHECKUP TWO WEEKS PRIOR TO REPORT AND THEIR HEALTHCARE PROVIDER USED THE CLINICIAN PROGRAMMER TO READ THE PATIENT¿S DEVICE . IT WAS STATED, THE HEALTHCARE PROVIDER COULDN¿T GET THE CLINICIAN PROGRAMMER TO REGISTER WITH THE PATIENT¿S DEVICE. IT WAS NOTED THEY COULDN¿T ¿GET A SIGNAL OR ANYTHING¿ WITH THE PROGRAMMER AND THE PATIENT DIDN¿T FEEL ANYTHING. IT WAS STATED, THE PATIENT¿S PROGRAMMER WORKED FINE AND SYNCHED WITH THE PATIENT¿S DEVICE. REPORTEDLY, IT SHOWED THE PATIENT¿S STIMULATION WAS SET AT 3.0 VOLTS AND THE PATIENT ALSO HAD AN X-RAY THAT DAY THAT SHOWED THEIR LEADS WERE OKAY AND HAD NOT DISLODGED OR ANYTHING. IT WAS NOTED A YEAR PRIOR TO REPORT, THE PATIENT¿S HEALTHCARE PROVIDER CHECKED THE DEVICE AND THEY STOOD UP AND HAD NO PROBLEMS SO THE PATIENT THOUGHT MAYBE THE REASON WAS BECAUSE, THEY WERE SITTING DOWN THIS TIME. IT WAS LATER REPORTED, THE PATIENT¿S DEVICE WAS REPLACED BECAUSE, THE ¿WIRE AND IMPLANT WERE NOT GOOD.¿ IT WAS STATED, THE PATIENT¿S DEVICE WAS NOT WORKING PROPERLY AND IT WAS NOTED THIS WAS DETERMINED AT THEIR CHECKUP APPOINTMENT IN (B)(6) 2014. IT WAS NOTED, THE HEALTHCARE PROVIDER COULDN¿T GET THE CLINICIAN PROGRAMMER TO CONNECT WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE DAY THEIR DEVICE WAS REPLACED IT WAS DISCOVERED THAT THE WIRE WAS NOT WORKING EITHER. IT WAS NOTED, THE PATIENT ONLY HAD THE IMPLANT FOR 18 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406290 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention