BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4167396 · Received October 13, 2014

    Report

    Report Number
    3004209178-2014-19572
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    August 4, 2014
    Report Date
    July 16, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V501927, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4). 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V501927, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID (B)(4) LOT# V501927 SERIAL# IMPLANTED: (B)(6) 2010 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID (B)(4) LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT MEDTRONIC, INC. (IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS FOUND TO BE OFF. THE DEVICE WAS TURNED BACK ON. THE PATIENT OUTCOME WAS UNKNOWN AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT'S OLD IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNING OFF BY ITSELF. THE HEALTHCARE PROFESSIONAL (HCP) FELT THAT THIS WAS LIKELY DUE TO THE BATTERY BEING CLOSE TO END OF LIFE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS ACHIEVING EFFICACY AND THERE WAS NO ISSUES NOW. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE DEVICE WAS OFF FOR AN UNKNOWN AMOUNT OF TIME. THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647539 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR