BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3921595 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12688
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V127156, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3093-28, LOT# V127156, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3093-28, LOT# V127156, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEA DS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS GETTING 50% OR GREATER SYMPTOM REDUCTION. THE CAUSE OF THE EVENT WAS DETERMINED. THE COMPONENT INVOLVED WITH THIS EVENT WAS THE LEAD. THE PATIENT DEVICE SYSTEM WAS EXPLANTED AND THE LEAD WAS PARTIALLY REMOVED BUT INACTIVE. AS IT WAS PREVIOUSLY REPORTED TNE PATIENT GAINED 100LBS SINCE INITIAL PLACEMENT AND HAD MULTIPLE FALLS. THE PATIENT WAS REPROGRAMMED, AN X-RAY WAS PERFORMED AS TROUBLESHOOTING. IT WAS NOTED THAT IT WAS NOT DEVICE RELATED. THE PATIENT DEVICE SYSTEM WAS EXPLANTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED BEING ABLE TO MAKE ADJUSTMENT ONLY WHEN ANTENNA WAS ATTACHED. IT WAS INDICATED THAT PATIENT WAS AT THE HEALTH CARE PROVIDER OFFICE A DAY PRIOR TO THE CALL SHE NEEDED THE ANTENNA BECAUSE SHE WAS USING IT WITHOUT THE ANTENNA AND COULD NOT LOCATE HER ANTENNA. THE PATIENT INDICATED THAT THERE WAS SOMETHING GOING, SHE HAD GAINED WEIGHT AND HER ANTENNA HAD TO BE UP AGAINST HER TO FIND IT AND HCP TOLD PT TO LET HCP KNOW IF IT WAS WORKING PROPERLY AND IF NOT THEN IN TWO WEEKS IF IT WAS NOT PT WOULD NEED TO HAVE IT REPLACED. IT WAS INDICATED THAT THE IMPLANT INSIDE OF THE BODY HAD MOVED BECAUSE WEIGHT CHANGED AND SHE HAD TO HAVE THE ANTENNA TO MATCH IT UP. IT WAS INDICATED THAT THE REASON WHY HCP TOLD PATIENT TO MONITOR IT FOR TWO WEEKS WITH ANTENNA WAS TO SEE IF IT WOULD CONNECT BUT IF IT DID NOT T THEN PATIENT MAY HAVE TO GET SURGERY. IT WAS INDICATED THAT THEY USED THE CLINICIAN PROGRAMMER AND IT COMMUNICATED AND STATED IT WAS HARD TO GET A READING AND HAD TO STICK IT TO THE SIDE AND BARELY GOT A READING. THE PATIENT INDICATED THAT THE CONTACTS ALONG THE LEAD THEY HAD TO CHANGE AND REPROGRAM TO GET WORKING. IT WAS INDICATED THAT THEY ARE CHECKING TO MAKE SURE IT HAD NOT FLIPPED INSIDE. IT WAS INDICATED THAT PATIENT WAS TO TURN IT UP 3, 2, 1, WITHOUT HER ANTENNA BUT COULD NOT DO THIS. IT WAS INDICATED THAT WHEN THE PATIENT HELD THE PROGRAMMER UP TO THE NEUROSTIMULATOR AND SYNCHED IT WOULD NOT CONNECT. THE PATIENT INDICATED THAT THE ISSUE WITH THE PROGRAMMER STARTED A MONTH AGO. IT WAS REPORTED THAT THE DEVICE WOULD NOT DO TELEMETRY. THE PATIENT LOST THEIR ANTENNA AND PROGRAMMER WON¿T CONNECT WITHOUT. APPEARS TO HAVE OCCURRED THROUGH PRODUCT USE. NO PATIENT HARM REPORTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400056 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention