BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3007331 · Received March 15, 2013

    Report

    Report Number
    3004209178-2013-03813
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Report Date
    March 1, 2013
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-33 LOT# V142285, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 NOTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD AN INCREASE IN URINARY INCONTINENCE ABOUT "A WEEK TO 10 DAYS AGO." THERE WAS NO STIMULATION SENSATION. THE PATIENT TURNED INS UP TO 6.0V AND COULD NOT FEEL STIM. IT WAS ALSO NOTED THAT THE PATIENT NEVER FELT THE STIM. THE EVENT OCCURRED FOLLOWING A FALL. THE PATIENT FELL THE (B)(6) AND THE (B)(6). THE PATIENT SAW THE HEALTHCARE PROVIDER AND HAD INS CHECKED. AN XRAY WAS PERFORMED AND THE HEALTHCARE PROVIDER HOOKED A MACHINE UP TO INS TO CHECK IT. EVERYTHING WAS FINE. THE PATIENT WAS ON PROGRAM 1 @ 6.0V. THEY CHANGED TO PROGRAM 2 @ 4.2V. THE PATIENT FELT STIM BUT THEN "IT WENT AWAY." THE PATIENT HAD CONCERNS ABOUT USING THE PROGRAMMER. THE PATIENT DID RECEIVE TRAINING BUT SHE HAD A CONCENTRATION AND MEMORY PROBLEM.

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE PATIENT¿S HEALTHCARE PROVIDER INDICATED THAT PATIENT OUTCOME WAS A NON-SERIOUS ILLNESS AND THE PATIENT DID NOT REQUIRE HOSPITALIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT THE PATIENT FELL ON (B)(6) 2013 AND HER INCONTINENCE WAS BAD AFTER THAT. IT WAS NOTED THAT THE PATIENT ALSO FELL THE SUNDAY BEFORE THE REPORT. IT WAS REPORTED THAT THE PATIENT HAD AN X-RAY THE WEEK PRIOR TO THE REPORT TO MAKE SURE THE LEAD HAD NOT MOVED, AND HER HEALTHCARE PROVIDER (HCP) SAID THAT NOTHING MOVED. THE REPORTER STATED THAT THE PATIENT SAW HER HCP THE WEEK BEFORE THE REPORT AND HER INCONTINENCE WAS BETTER AND THE PATIENT DIDN'T HAVE INTERSTIM ON. IT WAS NOTED THAT THE PATIENT PREVIOUSLY HAD STIMULATION ON 6.0 VOLTS, BUT TURNED IT DOWN BEFORE TURNING THE DEVICE BACK ON. IT WAS REPORTED THAT THE PATIENT TURNED THE DEVICE ON, TURNED STIMULATION TO 5.5 VOLTS, AND DECIDED TO LEAVE IT THERE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109479 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR