BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2355192 · Received December 1, 2011

    Report

    Report Number
    3004209178-2011-09525
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Report Date
    June 4, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3093, LOT# V072754, IMPLANTED:2008-(B)(6), EXPLANTED:NA; PROGRAMMER MODEL 3037, LOT# NJD060244N.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR LOW BATTERY ICON WAS DISPLAYED ON THE PATIENT'S PROGRAMMER. THE PATIENT HAD THE NEUROSTIMULATOR SET AROUND 3.0 VOLTS, AND IT WAS EXPECTED THAT THE DEVICE WOULD LAST LONGER. THE STIMULATION THERAPY WAS STILL HELPING WITH THE PATIENT'S SYMPTOMS. BUT, THE PATIENT WAS CONSIDERING NOT REPLACING THE NEUROSTIMULATOR. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS CONCERNED ABOUT THEIR IMPLANTABLE NEUROSTIMULATOR (INS). AN APPOINTMENT WAS SCHEDULED WITH THEIR PHYSICIAN ON 2011-(B)(6). ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS SEEN BY THEIR HEALTH CARE PROVIDER AND THEY COULD NOT GET A READING AND INDICATED THAT THE INS WAS DEPLETED. THE INS WAS HELPING WITH THE PATIENT'S BLADDER SYMPTOMS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY. IT WAS ALSO NOTED THAT THEY DO NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY AND THAT THEY HAVE WORKED WITH A PHYSICIAN. IT WAS INDICATED THAT THE INS ONLY LASTS 4 YEARS. THE PATIENT FELT THAT THE INS SHOULD LAST 10 YEARS, SIMILAR TO THEIR PACEMAKER. PATIENT OUTCOME WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT ON (B)(6) 2012 THE PATIENT HAD FREQUENCY, SOME URGENCY, NOCTURIA 2-3 TIMES PER NIGHT, SLOW STREAM AND SOME EPISODES OF URINARY RETENTION IN THE PAST. IT WAS STATED, THE PATIENT HAD NO RETENTION OR URINARY TRACT INFECTIONS IN OVER A YEAR. IT WAS NOTED, THE PATIENT¿S SYMPTOMS HAD BEEN INTERMITTENT. REPORTEDLY, THE PATIENT¿S DEVICE QUIT RESPONDING AND THEY HAD TURNED IT OFF FOR MORE THAN TWO MONTHS PRIOR TO (B)(6) 2012. IT WAS STATED THE DOCTOR DID NOT THINK THEY NEEDED THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1