BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 9159524 · Received October 5, 2019

    Report

    Report Number
    3004209178-2019-19062
    Event Type
    Malfunction
    Date Received
    October 5, 2019
    Report Date
    October 5, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994287724
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT#: V241897, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093-28, SERIAL/LOT #: (B)(4), UBD: 16-APR-2013, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). HCP REQUESTED MRI INFORMATION RELATED TO A LEAD FRAGMENT IN THE PATIENT WASN'T REMOVED DURING EXPLANT. IT IS UNKNOWN AS TO WHETHER OR NOT THE LEAD FRAGMENT WAS INTENTIONALLY LEFT IN AS WELL AS WHY THE SYSTEM WAS EXPLANTED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT STATED THAT HER ENTIRE INTERSTIM SYSTEMS WERE REMOVED EXCEPT FOR HALF AN INCH OF LEAD WHICH BROKE (LOCATED NEAR A SACRAL NERVE). PROCEDURE WAS DONE BY DOCTOR ON (B)(6) 2017. NO PATIENT SYMPTOMS AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954018 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994287724

    Patients

    Seq Age Sex Outcome Treatment
    1