BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3240758 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12089
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 25, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 309510 LOT# SERIAL# (B)(4) IMPLANTED: 2003 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3093 LOT# J0343913V, IMPLANTED: 2003 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS, MODEL 3023, SERIAL NO (B)(4), FOUND NO SIGNIFICANT ANOMALY, FUNCTIONALLY OKAY, AND INSIGNIFICANT ANOMALIES. ANALYSIS OF THE EXTENSION, MODEL 309510, SERIAL NO. (B)(4), FOUND NO ANOMALIES. ANALYSIS OF THE LEAD, MODEL 3093, FOUND THE LEAD BODY CONDUCTOR BROKEN (OVERSTRESS/DAMAGE). ALL CONDUCTORS BROKE 10.1 CM FROM THE DISTAL END, SUSPECTED THAT THE CONDUCTORS BROKE 9 CM FROM THE DISTAL END AT A PINCH IN THE LEAD. CONDUCTORS APPEARED TWISTED AND ALL CONDUCTORS BROKE 1.7 CM FROM THE PROXIMAL END.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN X-RAY SHOWED A COMPLETE LEAD FRACTURE NEAR THE EXTENSION, SO AN EXPLANT WAS SCHEDULED. DURING THE EXPLANT, THE PHYSICIAN NOTICED THE WIRE WITHIN THE LEAD WAS ALSO FRACTURED WHILE STILL INSIDE THE SHEATHING FURTHER DOWN THE LEAD. IT WAS BELIEVED THAT THIS FRACTURE OCCURRED BEFORE THE EXPLANT WAS INITIATED. IT WAS NOTED THAT THE LEAD, EXTENSION AND DEVICE WERE ALL EXPLANTED. THERE WERE NO PATIENT SYMPTOMS/INJURIES REPORTED WITH RESPECT TO THIS EVENT AND THE PATIENT STATUS WAS REPORTED AS NO INJURY/NO ADVERSE EVENT. 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
    340518 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention