BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5065068 · Received September 9, 2015

    Report

    Report Number
    3004209178-2015-17603
    Event Type
    Injury
    Date Received
    September 9, 2015
    Report Date
    August 17, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 3889-28, LOT# V498894, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE REPORTED VIA THE PATIENT THAT THE PATIENT WAS A POTENTIAL REPLACEMENT PATIENT (PRP). A FOLLOW-UP APPOINTMENT WITH THE PATIENT'S HEALTH CARE PROVIDER (HCP) WAS MADE. THE PATIENT'S DEVICE WAS EXPLANTED LAST (B)(6). THE BATTERY WAS DEPLETED SO THEY REMOVED IT. THE PATIENT GOT A (B)(6) INFECTION AFTER HAVING THE DEVICE REMOVED. THE PATIENT ALSO STATED THAT THE HEALTH CARE PROVIDER (HCP) WANTED TO DO BOTOX BUT SHE WAS A LITTLE WEARY OVER IT. THE INDICATION-FOR-USE WAS SACRAL NERVE STIM/URINARY DYSFUNCTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT SHE NOW HAD PROBLEMS ABOVE HER L4 AND L5 AND SHE HOPED ALL OF THE INFECTION DID NOT WEAKEN A DISC THAT HAD A TEAR WHICH HAD NOW PROGRESSED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT HER RIGHT SACRAL NERVE WAS DEAD, SO SHE ONLY HAD THE LEFT SACRAL NERVE THAT COULD BE USED FOR THE DEVICE. IN 2010, WHEN THE DEVICE WAS PUT IN, THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS PUT IN HER RIGHT BUTTOCK AND THE LEADS TO THE LEFT NERVE, THUS STRETCHING THE LEADS ACROSS THE SPINE AT APPROXIMATELY L3. THE PATIENT HAD ASKED THAT THE BATTERY BE KEPT AWAY FROM L4-L5 ON THE LEFT SIDE AND NOTED THAT THE BATTERY SHOULD HAVE BEEN PLACED CLOSE TO THE LEADS AND WAS A "BAD MISTAKE." SYMPTOMS OF THE INFECTION INCLUDED SERIOUS DRAINAGE FROM A LEFT BUTTOCK WOUND FOR OVER A WEEK. IT WAS CHECKED BY THE CLINIC AND THE DRESSING CONTINUED TO BE CHANGED WITH NO ANTIBIOTICS. WHEN THE INFECTION KEPT ON INTO WEEK TWO, IT WAS CULTURED AND STAPH WAS FOUND. THE PATIENT SPENT TWO WEEKS "SCARED OUT OF [HER] MIND" BECAUSE IT WAS SO CLOSE TO THE SPINE AND SHE HAD A LARGE SURGERY DONE IN 2012 WITH BONE GRAFTS. MEDICATION AND FREQUENT DRESSING CHANGES DUE TO THE LIQUID EXPELLED FROM THE LEAD SITE WERE DONE TO RESOLVE THE INFECTION. SHE THOUGHT THE DRAINAGE WAS CAUSED WHEN THE LEADS PULLED ACROSS THE SPINE AREA FROM THE BATTERY. IT MADE AN "ELONGATED ROAD" TO POOL AND CAUSE BACTERIA GROWTH. THE PATIENT MISSED THE DEVICE AND WOULD REPLACE IT BUT HAD TO WAIT UNTIL THE LEADS WERE UPDATED FOR MRIS. IT WAS UNKNOWN WHAT SCAR TISSUE SHE NOW HAD, AS SHE FORMED ADHESIONS EASILY IN THE AREA OF THE STAPH INFECTION. NO POTENTIAL CAUSES WERE REPORTED REGARDING THE BATTERY DEPLETION OR BATTERY PLACEMENT. 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 #3004209178-2014-13654 FOR ADDITIONAL ISSUES THE PATIENT EXPERIENCED WHILE THE DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596742 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention