BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1812177 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-06155
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT'S IMPLANTED DEVICE HAD HIGH IMPEDANCES - GREATER THAN 4000 OHMS ON ALL OF THE UNIPOLAR PAIRS. THE PT ALSO HAD LOSS OF THERAPEUTIC EFFECT. FURTHER INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT# J0555568V| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH001449V| PROGRAMMER: MODEL 3031A, LOT# NGM010561P