BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7079708 · Received December 4, 2017

    Report

    Report Number
    3004209178-2017-24803
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 4, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3093-28, LOT# V103459, IMPLANTED: (B)(6) 2008 EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A VIA THE MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM/GASTROINTESTINAL AND PELVIC FLOOR. IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL ACCIDENTALLY CUT LEAD DURING REMOVAL IN A ROUTINE BATTERY REPLACEMENT. A NEW LEAD WAS USED AND ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WAS NOTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860465 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR