BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3494951 · Received December 2, 2013

    Report

    Report Number
    3004209178-2013-21683
    Event Type
    Injury
    Date Received
    December 2, 2013
    Report Date
    November 9, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 093-33 LOT# V042644, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD THEIR LEAD CHANGED FROM ONE SIDE TO THE OTHER THE DAY PRIOR TO REPORT AND IT WASN¿T SYNCHING RIGHT BUT THOUGHT IT WAS FIXED. IT WAS NOTED THE PATIENT KNEW SOMETIMES THE ¿PANTS COULD CREATE AN ISSUE BUT IT DID WORK OTHER TIMES.¿ THE PATIENT PULLED HER PANTS DOWN AND IT WORKED WITH THE PROGRAMMER. IT WAS EXPLAINED THE PATIENT HAD A LEAD REVISION THE DAY PRIOR TO REPORT BECAUSE IN (B)(6) 2013 THE LEAD WAS ON THE RIGHT SIDE AND IT DIDN¿T WORK PROPERLY, AS WELL AS WHEN IT WAS ON THE LEFT SIDE DURING THE TRIAL PERIOD, SO THE LEAD WAS PUT ON THE LEFT SIDE. THE PATIENT WAS ABLE TO SYNC. THE PATIENT STATED THEY THINK THEY FIGURED IT OUT AND GOT THE PROGRAMMER TO DO WHAT THEY NEEDED IT TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623007 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention