BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2102331 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-03694
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THE HCP RECEIVED THE POWER ON RESET SCREEN ON THE PHYSICIAN PROGRAMMER. THE PATIENT HAD BEEN IN THE HOSPITAL THE WEEK BEFORE. THE HCP WAS INSTRUCTED BY THE MANUFACTURER'S TECHNICAL SERVICES ON HOW TO SYNCHRONIZE DEVICES. THE HCP WAS PLANNING TO REPROGRAM THE PATIENT THAT AFTERNOON. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT. REFERENCE MFR REPORT # 3004209178-2011-03693 FOR RELATED NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 H0308969

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR EXPLANTED:| LOT# NJY157587H| IMPLANTABLE NEURO STIMULATOR: MODEL 3058| IMPLANTED:| LEAD: MODEL 3889, LOT# V593554| IMPLANTED:| LEAD: MODEL 3093, LOT# V399016| IMPLANTED:| EXPLANTED:| EXPLANTED: