BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 6387361 · Received March 8, 2017

    Report

    Report Number
    3004209178-2017-05212
    Event Type
    Injury
    Date Received
    March 8, 2017
    Date of Event
    January 1, 2015
    Report Date
    March 8, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994756558
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3093-28 LOT# J0322054V SERIAL# IMPLANTED: 2003-08-11 EXPLANTED: (B)(6) 2015 PRODUCT TYPE LEAD PATIENT CODE C76143 PERTAINS TO BOTH IPG (NBV144450H) AND TINED LEAD (J0322054V) DEVICE CODE C76126 PERTAINS TO IPG (NBV144450H) DEVICE CODE C62955 PERTAINS TO TINED LEAD (J0322054V) EVALUATION CODE 92 PERTAINS TO TINED LEAD (J0322054V). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PATIENT REPORTED A LEAD ISSUE. IT WAS REVIEWED THE IMPLANTABLE NEUROSTIUMULATOR (INS) WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. THE PATIENT NOTED THE LEAD WAS ALSO REPLACED DUE TO ¿ONLY 2 WIRES WORKING INSTEAD OF 4. IT WASN¿T WORKING RIGHT.¿ IT WAS NOTED PATIENT SERVICE REVIEWED THE PATIENT ONLY HAD ONE WIRE, BUT MAY HAVE BEEN REFERRING TO THE ELECTRODES. THE PATIENT DID NOT KNOW THE ISSUE WITH THE LEAD, EXTENSION, OR ADAPTER. IT WAS NOTED THE PATIENT HAD A REVISION ON (B)(6) 2015 AND THEY COMPLETELY RECOVERED. IT WAS NOTED THERE WAS NO MENTION ON ANY LEAD ISSUES FOLLOWING THE REVISION AND IT APPEARED TO HAVE RESOLVED THE ISSUE ISSUE. THE PATIENT IS IMPLANTED OR GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170281 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023 00613994756558

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention