BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5131981 · Received October 7, 2015

    Report

    Report Number
    3004209178-2015-20140
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    August 20, 2015
    Report Date
    September 10, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS FOR THE IMPLANTABLE NEUROSTIMULATOR OR LEAD WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT # VA0W04G, IMPLANTED: (B)(6) 2015 PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND NO ANOMALIES WITH THE RETURNED LEAD (UNKNOWN SERIAL NUMBER) AND IMPLANTABLE NEUROSTIMULATOR ((B)(4)).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THERE WAS A LEAD ISSUE THAT WAS MIGRATION/DISLODGEMENT. THE EVENT STARTED OUT AS A LEAD MIGRATION THAT WAS TO BE REVISED BUT WHEN THE BATTERY CAPACITY WAS CHECKED WITH THE PROGRAMMER IT SHOWED ¿BATTERY 5 MOS.¿ THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO LONGEVITY THAT WAS REPORTED AS 5-12 MONTHS WITH 38-85% CAPACITY. THE PATIENT HAD THE DEVICE TURNED TO 8.5 BECAUSE WITH THE MIGRATION OF THE LEAD SHE WASN¿T FEELING STIMULATION SO THEN THE BATTERY DRAINED. THE MANUFACTURER REPRESENTATIVE WAS CONTACTED AND REPORTED THAT THEY "DID NOT RECEIVE BENEFIT ON WITH PROGRAMMING" SO AN X-RAY WAS TAKEN AND INDICATED THE LEAD HAD MIGRATED. THE LEAD WAS TWISTED OR COILED. THE LEAD ROLLED INTO THE FORAMEN. THE LEAD WAS REMOVED AND DISCARDED. THE INS HAD ALSO MOVED. THIS HAD PREVENTED THE PATIENT FROM GETTING ANY THERAPY. THE INS WAS REPLACED AND THE DEFECTIVE ONE WAS RETURNED. THE REVISION OCCURRED ABOUT 3 WEEKS AGO IN (B)(6) 2013. THE BATTERY REPLACEMENT OCCURRED THE DAY OF THE REPORT ((B)(6) 2015). THE PATIENT OUTCOME WAS UNKNOWN. IT WAS UNKNOWN WHAT THE MANUFACTURER REPRESENTATIVE KNEW ABOUT THE LEAD MIGRATION. THE INDICATIONS FOR USE WERE URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THERE WAS AN INVALID IMPEDANCE ISSUE ON (B)(6) 2015. DURING THE LEAD REVISION THE REPRESENTATIVE RERAN IMPEDANCE AT 2 AND 300 PULSE WIDTH AND GOT CASE AND 1 AT ??? AND CASE AND 2 AT ???. THE REPRESENTATIVE RERAN AT 2 VOLTS AND 360PW AND ALL VALUES CAME BACK WITHIN RANGE. CALLER NEEDED TO COMPLETE CASE. THE REVISION HAD OCCURRED. CASE WAS IN PROGRESS WHILE CALL TOOK PLACE. THERE WAS NO ALLEGATION OF SYSTEM USE ISSUE DURING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662851 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention