BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3551520 · Received January 3, 2014

    Report

    Report Number
    3004209178-2014-00153
    Event Type
    Malfunction
    Date Received
    January 3, 2014
    Report Date
    December 13, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # V850461, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COUPLE MONTHS PAST IMPLANT, THE PATIENT¿S THERAPY STOPPED WORKING FOR HIM. THE PATIENT STATED THAT THE MANUFACTURER REPRESENTATIVE TRIED SIX TO SEVEN TIMES TO REPROGRAM AND ADJUST HIS THERAPY. THE THERAPY WOULD WORK FOR A FEW DAYS AFTER EVERY ADJUSTMENT AND THEN THE PATIENT WOULD STOP FEELING STIMULATION SENSATION. THE PATIENT WAS BACK TO GOING TO THE BATHROOM THREE TO FOUR TIMES PER NIGHT AND THE THERAPY HAD NOT WORKED FOR A LONG TIME. THE PATIENT WENT TO SEE HIS DOCTOR, WHO ORDERED AN X-RAY, AND TOLD HIM THAT ¿HIS CONNECTORS WERE BROKEN.¿ THE DOCTOR TOLD THE PATIENT HE WOULD NEED SURGERY AGAIN AND HE THOUGHT THE LEAD WIRES HAD BEEN BROKEN SINCE RIGHT AFTER IMPLANT. A WEEK LATER THE PATIENT CLARIFIED THAT HE BEGAN REPROGRAMMING WITH THE MANUFACTURER REPRESENTATIVE THREE MONTHS AFTER IMPLANT. THE PATIENT WOULD ONLY FEEL STIMULATION SENSATION FOR A DAY AND IT WOULD GO AWAY AND THEY HAD TO KEEP GOING HIGHER AND HIGHER. LATER THAT DAY THE PATIENT REPORTED THAT HE BEGAN WORKING WITH THE REPRESENTATIVE AFTER ONE TO TWO MONTHS, NOT THREE LIKE PREVIOUSLY MENTIONED. THE PATIENT SAW THE REPRESENTATIVE SEVEN TO EIGHT TIMES TO ¿RESET¿ THE DEVICE. THE PATIENT ALSO SAW HIS DOCTOR ¿ABOUT ONE MONTH AGO¿ AND THE DOCTOR STATED THE LEAD BROKE OFF. 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
    4462 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1