BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 10413937 · Received August 17, 2020

    Report

    Report Number
    2182207-2020-00715
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    January 1, 2018
    Report Date
    January 14, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: NEU UNKNOWN, LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    HARRIES F. INTRODUCTION TO SACRAL NEUROMODULATION THERAPY FOR URINARY BLADDER DYSFUNCTION USING AN INTERSTIM SYSTEM. BR J NURS. 2020. 29(9):S23-S26. DOI: 10.12968/BJON.2020.29.9.S23 SUMMARY: SACRAL NEUROMODULATION IS AN INTERNATIONALLY ENDORSED THERAPY RECOGNISED BY THE NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE FOR PATIENTS WHO HAVE REFRACTORY OVERACTIVE BLADDER SYMPTOMS AND/OR IDIOPATHIC NON-OBSTRUCTIVE URINARY RETENTION WHEN CONSERVATIVE TREATMENTS HAVE FAILED OR WHEN PATIENTS HAVE BEEN UNABLE TO TOLERATE THEM. THE MEDTRONIC INTERSTIM SYSTEM USED AT THE QUEEN ELIZABETH HOSPITAL BIRMINGHAM RECEIVED CE MARK APPROVAL IN 1995 FOR BLADDER INDICATIONS. TO DATE, OVER 300 000 PATIENTS WORLDWIDE HAVE BEEN TREATED, WITH 61¿90% REPORTING SATISFACTION WITH TREATMENT (SUTHERLAND ET AL, 2007; LEONG ET AL, 2011). IT IS A SAFE AND EFFECTIVE INTERVENTION THAT CAN POSITIVELY IMPACT UPON THE MANAGEMENT OF BOTH OF THESE CONDITIONS, IN PARTICULAR OVERACTIVE BLADDER. THIS HIGHLY PREVALENT CONDITION IS DISTRESSING TO THE INDIVIDUAL AND HAS AN ECONOMIC BURDEN TO SOCIETY COMPARABLE IN MAGNITUDE WITH THAT OF BREAST CANCER AND OSTEOPOROSIS (HU AND WAGNER, 2005). REPORTED EVENT: A 17 YEAR OLD FEMALE EXPERIENCED A REVISION PROCEDURE IN 2018 DUE TO A LEAD MIGRATION FOLLOWING A FALL. SHE HAS BEEN LIVING A FULL AND ACTIVE LIFE AND HAS ENJOYED TRAVELLING EXTENSIVELY AROUND THE WORLD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    HARRIES F. INTRODUCTION TO SACRAL NEUROMODULATION THERAPY FOR URINARY BLADDER DYSFUNCTION USING AN INTERSTIM SYSTEM. BR J NURS. 2020. 29(9):S23-S26. DOI: 10.12968/BJON.2020.29.9.S23 SUMMARY: SACRAL NEUROMODULATION IS AN INTERNATIONALLY ENDORSED THERAPY RECOGNISED BY THE NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE FOR PATIENTS WHO HAVE REFRACTORY OVERACTIVE BLADDER SYMPTOMS AND/OR IDIOPATHIC NON-OBSTRUCTIVE URINARY RETENTION WHEN CONSERVATIVE TREATMENTS HAVE FAILED OR WHEN PATIENTS HAVE BEEN UNABLE TO TOLERATE THEM. THE MEDTRONIC INTERSTIM SYSTEM USED AT THE QUEEN ELIZABETH HOSPITAL BIRMINGHAM RECEIVED CE MARK APPROVAL IN 1995 FOR BLADDER INDICATIONS. TO DATE, OVER 300 000 PATIENTS WORLDWIDE HAVE BEEN TREATED, WITH 61¿90% REPORTING SATISFACTION WITH TREATMENT (SUTHERLAND ET AL, 2007; LEONG ET AL, 2011). IT IS A SAFE AND EFFECTIVE INTERVENTION THAT CAN POSITIVELY IMPACT UPON THE MANAGEMENT OF BOTH OF THESE CONDITIONS, IN PARTICULAR OVERACTIVE BLADDER. THIS HIGHLY PREVALENT CONDITION IS DISTRESSING TO THE INDIVIDUAL AND HAS AN ECONOMIC BURDEN TO SOCIETY COMPARABLE IN MAGNITUDE WITH THAT OF BREAST CANCER AND OSTEOPOROSIS (HU AND WAGNER, 2005). REPORTED EVENT: A (B)(6) YEAR OLD FEMALE EXPERIENCED A REVISION PROCEDURE IN 2018 DUE TO A LEAD MIGRATION FOLLOWING A FALL. SHE HAS BEEN LIVING A FULL AND ACTIVE LIFE AND HAS ENJOYED TRAVELLING EXTENSIVELY AROUND THE WORLD. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881396 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention "SEE H10...."