BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3914262 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12551
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 11, 2014
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3 889-28, LOT# V505195, IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3095-10. SERIAL# (B)(4), IMPLANTED: 2010-(B)(6). PRODUCT TYPE EXTENSION. PRODUCT ID NEU_UNKNOWN_EXT, IMPLANTED: 2010-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING ¿ZAPPING IN HER BUTT¿ THAT STARTED IN FEBRUARY OR MARCH. IN MAY, THE PATIENT SAW HER HEALTHCARE PROVIDER (HCP) FOR HER SIX-MONTH CHECK-UP, THEY TRIED A DIFFERENT PROGRAM, AND THE PATIENT WASN¿T GETTING ZAPPED BUT IT WASN¿T WORKING AS WELL. THE HCP CHECKED THE IMPLANTABLE NEUROSTIMULATOR (INS) AND SAID THE INS WAS FINE, BUT THE PATIENT WASN¿T SURE IF SHE BELIEVED THE HCP SINCE SHE HAD BEEN ZAPPED FOR A WHILE. IT WAS LATER REPORTED THAT THERE WAS 50% OR GREATER SYMPTOM REDUCTION, THE INS WAS INVOLVED IN THE EVENT, AND THE CAUSE OF THE EVENT WAS DETERMINED AND WAS DEVICE RELATED. A MANUFACTURER REPRESENTATIVE WAS NOTED AS AN ¿ACTION TAKEN TO RESOLVE ISSUE.¿ THE PATIENT HAD NOT RECOVERED AND THE SYMPTOMS AND ISSUE WERE ONGOING. 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
    391420 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR