BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3001902 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03633
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    October 11, 2012
    Report Date
    February 19, 2013
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V386649, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013 THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED DUE TO PAIN FOLLOWING MULTIPLE FALLS. IT WAS STATED THAT THE PATIENT WAS IN "A LOT OF PAIN, AND THE PAIN WAS OVER THE IMPLANT SITE AND IT WENT TO HER GROIN AND TO HER BACK SOMETIMES." IT WAS NOTED THAT THE PATIENT WAS FEELING PAIN WHEN THE DEVICE WAS ON AND OFF AND WAS FEELING PAIN "AFTER 10 MINUTES WHEN BEING ON HER FEET." WHILE STIMULATION WAS TURNED ON, THE CALLER STATED SHE GOT A FOOT CRAMP FROM "HAVING THE STIMULATION ON AFTER A FEW MONTHS." REPORTEDLY, THE PATIENT HAD TO TURN THE INS OFF AND BACK ON FOR IT TO STOP. THE CALLER STATED SHE FELL ON (B)(6) 2012 AND "BROKE HER BACK IN THREE PLACES AND THEN ON (B)(6) 2012 SHE FELL AND MISSED A STEP AND THIS WAS WHEN THE PAIN FROM INS STARTED, SHE ALSO FELL ON 2013-01-02." THE CALLER ALSO STATED SHE HAD AN X-RAY AND CT SCAN DONE AND "EVERYTHING LOOKED GOOD SO IT HAD TO BE THE IMPLANT." IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT DID NOT HAVE ANY CONCERNS WITH HER DEVICE, AND SHE RECEIVED ASSISTANCE AND HER CONCERNS WERE RESOLVED ON THE PAST APPOINTMENT DATES, (B)(6) 2013. IT WAS THEN REPORTED ON (B)(6) 2013 THAT THE PATIENT HAD FALLEN SEVERAL TIMES, INCLUDING (B)(6) 2012. IT WAS STATED HER INS WAS REPLACED ON (B)(6) 2013 AND SHE HAD NOT FALLEN SINCE, AS OF THE DAY OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S PAIN HAD BEEN OCCURRING SINCE BEFORE THE REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) IN (B)(6) 2013. IT WAS STATED THAT THE HEALTH CARE PROVIDER TRIED TO REVISE THE POCKET BUT WAS UNSUCCESSFUL DUE TO THE LEAD WIRE NOT BEING LONG ENOUGH. IT WAS ALSO STATED THAT THE PATIENT HAD TO TURN THE INS OFF AT NIGHT DUE TO LEG CRAMPING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105486 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention