BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY VERSITREL

    MDR report key: 2448690 · Received February 13, 2012

    Report

    Report Number
    3004209178-2012-00951
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Report Date
    January 20, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL 3093-28 LOT# V195597 IMPLANTED: (B)(6) 2009 EXPLANTED: NA, LEAD MODEL 3093-28 LOT# V161901 IMPLANTED: (B)(6) 2009 EXPLANTED: NA, EXTENSION MODEL 748910 SERIAL# (B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA, EXTENSION MODEL 748910 SERIAL# (B)(4)IMPLANTED: (B)(6) 2009 EXPLANTED: NA, PROGRAMMER MODEL 7435 SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A STRONG TUG ON THE SYSTEM WHILE BENDING OVER SEVERAL WEEKS AGO. FOLLOWING THE TUG THE PATIENT HAD NEW PAIN AT THE IMPLANTABLE PULSE GENERATOR SITE AND FELT THAT STIMULATION WAS IN A DIFFERENT LOCATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY VERSITREL STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 7427V-NP

    Patients

    Seq Age Sex Outcome Treatment
    1