BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2687596 · Received August 8, 2012

    Report

    Report Number
    3004209178-2012-06634
    Event Type
    Injury
    Date Received
    August 8, 2012
    Report Date
    July 9, 2012
    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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V203110, SERIAL#, IMPLANTED: 2009 (B)(6), EXPLANTED: PRODUCT TYPE LEAD, PRODUCT ID 3037, LOT#, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THAT SHE "WAS AT 4.0 OR 4.3 AND SHE FELT A POUNDING SENSATION THAT KEPT HER AWAKE". THE PATIENT WAS ADVISED BY HER MANUFACTURING REPRESENTATIVE TO TURN DOWN THE DEVICE SOMETIMES. . THE PATIENT STATED THAT HER INCONTINENCE STARTED A FEW DAYS AFTER HER PHYSICIAN'S APPOINTMENT ON (B)(6) 2012. THE PATIENT FURTHER STATED THAT HER PHYSICIAN "DECREASED HER STIMULATION TO 2.0 ON PROGRAM 3", WHICH DECREASED THE PATIENT'S BLADDER CONTROL. IT WAS NOTED THAT THE PATIENT WAS "LEAKING URINE AND NEVER HAD THE URGE" IT WAS NOTED THAT THE "POOR COMMUNICATION" ICON WAS DISPLAYED WITH OR WITHOUT USING THE PROGRAMMER ANTENNA AND THAT THE BATTERIES HAD BEEN CHANGED IN THE PROGRAMMER. IT WAS FURTHER NOTED THAT THE PATIENT RECEIVED A REPLACEMENT PATIENT PROGRAMMER FROM THE MANUFACTURER, BUT NEITHER PROGRAMMER WAS ABLE TO COMMUNICATE WITH THE INTERNAL NEUROSTIMULATOR (INS) WITH OR WITHOUT THE ANTENNA. THE PATIENT STATED THAT SHE "HAD A BUMP AT THE IMPLANT SITE". THE PATIENT WAS ADVISED BY HER PHYSICIAN TO TAKE DESMOPRESSIN ONCE A DAY, BUT THE PATIENT STATED THAT SHE "SUFFERED SIDE EFFECTS FROM THE MEDICATION". THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention