BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3922107 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12695
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 17, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # VA0DDCC, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD STIMULATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) IN THE WRONG LOCATION, SPECIFICALLY, THE DORSIFLEXION OF THE RIGHT FOOT. THE PATIENT STATED THAT THEY WERE ¿NOT SURE¿ THAT THE INS DEVICE HAS EVER HELPED THEM AND HAD STIMULATION IN THE WRONG LOCATION WITH NO THERAPY RESULTS. IT WAS NOTED THAT THE PATIENT HAD DORSIFLEXION OF THE RIGHT FOOT AND TOES SINCE IMPLANTATION. IT WAS ADVISED TO TRY MULTIPLE ELECTRODE COMBINATIONS TO SOLVE THE ISSUE BUT EACH COMBINATION PROVIDED STIMULATION IN THE WRONG LOCATION. THE PATIENT ALSO FELT NO STIMULATION ON ELECTRODE CONTACT #0. IN ADDITION, IT WAS REPORTED THAT THE PATIENT DID NOT NORMALLY FEEL SHOCKING BUT DURING PROGRAMMING WITH THE NURSE THEY FELT SHOCKING WITH SOME OF THE ELECTRODE COMBINATIONS. THE PATIENT ALSO FELT SHOCKING DURING THE ELECTRODE IMPEDANCE TEST. IMPEDANCE TEST RESULTS SHOWED VALUES GREATER THAN 4,000 OHMS ON THE ELECTRODE COMBINATIONS OF #0 <(>&<)>1, 0 <(>&<)> 2, AND 0 <(>&<)> 3. ALL OTHER ELECTRODE COMBINATIONS VALUES RANGED FROM 1111 TO 2213. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CAUSE OF THE IMPEDANCE ISSUE WAS UNKNOWN. REGARDING ANY LEAD FRACTURES, IT WAS NOTED: NOT KNOWN. IT WAS NOTED: DEVICE OFF X SEVERAL WEEKS. ANOTHER DOCTOR PLACED THE DEVICE. IT NEVER WORKED. URODYNAMICS PERFORMED. REPROGRAMMING PERFORMED INCLUDING WITH ASSISTANCE FROM THE MANUFACTURER. PLAN REVISION WITH PRESERVATION OF CURRENT IPG IF FEASIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401331 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention