BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2223871 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06566
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    April 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED EITHER AN OVERSTIMULATION SENSATION OR AN UNDERSTIMULATION SENSATION, DEPENDING UPON HOW THE VOLTAGE PARAMETERS ON THE IMPLANTABLE NEUROSTIMULATOR WERE CHANGED. THE PT ALSO EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AS THE STIMULATION ONLY WORKED INTERMITTENTLY. THE PT MET WITH THE PHYSICIAN AND THE MFR REP ON (B)(6) 2011. THE DEVICE WAS CHECKED AND WAS WORKING WELL. IMPEDANCE READINGS WERE NORMAL AND THERE WAS APPROPRIATE STIMULATION SENSATION WHEN THE AMPLITUDE WAS INCREASED. SINCE IMPLANTATION OF THE DEVICE, THE PT DID NOT HAVE TO USE A CATHETER TO ELIMINATE URINE FROM THE BLADDER. PRIOR TO THE DEVICE IMPLANTATION, THE PT HAD TO CATHETERIZE THREE TIMES PER DAY. THE PHYSICIAN INSTRUCTED THE PATIENT THAT ALTHOUGH THERE MAY BE NO STIMULATION FELT, THE DEVICE WAS STILL WORKING. IT WAS LATER REPORTED THAT THE PT MET WITH THE PHYSICIAN AND THE MFR REP ON (B)(6) 2011. IT WAS NOTED THAT FOLLOWING IMPLANTATION OF THE DEVICE, THE PT VOIDED NORMALLY FOR SEVERAL MONTHS. THE PT'S SYMPTOMS RETURNED RECENTLY, HOWEVER. THE PT REQUIRED CATHETERIZATION. THE PT'S DEVICE WAS ADJUSTED AND PROVIDED OPTIMAL SENSORY RESPONSE AND MINIMAL SENSATION IN THE TOE. THE PT DISCUSSED A TREATMENT PLAN WITH THE PHYSICIAN. ADDITIONAL INFO WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE. SEE ALSO MFR REPORT # 3004209178-2011-06568.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention PROGRAMMER: MODEL 3037, LOT# NJD124810N| IMPLANTABLE NEURO STIMULATOR: MODEL 3058| IMPLANTED:| LEAD: MODEL 3889, LOT# V667643| LOT# NJY166348H| IMPLANTED:| LEAD: MODEL 3889, LOT# V596737| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: