BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2838598 · Received November 19, 2012

    Report

    Report Number
    3004209178-2012-10515
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    July 3, 2012
    Report Date
    October 23, 2012
    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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3095-10 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3093-28 LOT# V210133, IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DECREASE IN EFFICACY FOLLOWING A MOTOR VEHICLE ACCIDENT. IT WAS NOTED THAT THE PATIENT HAD GOOD SYMPTOM CONTROL PRIOR TO THE (B)(6) 2012 ACCIDENT. THE REPORTER STATED THAT AN X-RAY TAKEN IN THE EMERGENCY ROOM CONFIRMED THAT EVERYTHING WAS STILL INTACT. IT WAS STATED THAT THE MANUFACTURER REPRESENTATIVE AND PHYSICIAN "DID ALL THEY COULD WITH IT" AND DECIDED TO REPLACE THE SYSTEM. THE REPORTER STATED THAT ON (B)(6) 2012, A LEAD REVISION WAS PERFORMED ON THE LEFT SIDE, BUT A PORTION OF THE LEAD WAS LEFT IN THE PATIENT AND A NEW LEAD WAS IMPLANTED ON THE RIGHT SIDE. IT WAS NOTED THAT THE PATIENT WAS UNAWARE THAT A PORTION OF THE OLD LEAD REMAINED UNTIL AN X-RAY ON (B)(6) 2012. IT WAS STATED THAT THE PATIENT'S SYMPTOMS STILL DID NOT IMPROVE. THE REPORTER STATED THAT THE SYSTEM WAS SHUT OFF. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WOULD BE INCLUDED IN A FOLLOW-UP REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention