BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3032858 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04532
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# VA04CLH, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN "INFECTION IN HIS URINE" AND WAS ON ANTIBIOTICS. THE REPORTER STATED THAT THE PATIENT DIDN'T KNOW IF THE INFECTION WAS RELATED TO HIS DEVICE AND THE PATIENT'S HEALTHCARE PROVIDER DIDN'T SAY IF IT WAS RELATED OR NOT. IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT AND A LOSS OF BLADDER CONTROL. THE REPORTER STATED THAT IN THE LAST WEEK PRIOR TO THE REPORT THE PATIENT NOTICED THAT HE HAD TO GO TO THE BATHROOM EVERY HOUR. IT WAS REPORTED THAT SOMETIMES IT WAS EVERY TWO OR THREE HOURS BUT THE WEEK HAD "BEEN A BAD WEEK." IT WAS NOTED THAT THE PATIENT COULD FEEL STIMULATION COMFORTABLY BUT WAS NOT GETTING THE DESIRED THERAPEUTIC EFFECT. IT WAS REPORTED THAT THE PATIENT HAD NO KNOWN FALLS OR TRAUMA AND HAD BEEN RIDING HIS BICYCLE IN THE MORNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT REGARDING THE CAUSE OF THE EVENT: THE PATIENT DID NOT SEE IMPROVEMENT. ENTIRE DEVICE REMOVED: 2014-(B)(6). HOSPITALIZATION WAS NOT REQUIRED. PATIENT OUTCOME WAS NOTED AS NO INJURY. IT WAS NOTED: PATIENT DID NOT GET EXPECTED OUTCOME. PATIENT WAS SEEN MULTIPLE TIMES BY REPRESENTATIVE AND REPROGRAMMED AND CHECKED WITH NO IMPROVEMENT. THE MANUFACTURER'S REPRESENTATIVES SAW THE PATIENT FREQUENTLY AND TRIED THEIR BEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137108 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention