BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PISCES QUAD PLUS

    MDR report key: 2971431 · Received February 27, 2007

    Report

    Report Number
    2649622-2007-03242
    Event Type
    Malfunction
    Date Received
    February 27, 2007
    Date of Event
    November 22, 2006
    Report Date
    January 31, 2007
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    GZB
    PMA / PMN Number
    K923567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS RESULTS REVEAL THE #0 CONDUCTOR WIRE IS BROKEN; THE FRACTURE IS LOCATED 14.5-CM FROM THE DISTAL TIP. VISUAL EXAM SHOWS THE PRODUCT OUTER INSULATION MATERIAL IS PINCHED; MARKINGS OBSERVED IN THE OUTER INSULATION ARE LOCATED 15.8-CM FROM THE DISTAL TIP. SUSPECTED ANCHOR OR SUTURE SITE. INSPECTION SHOWS THE LEAD IS STRETCHED AT THE #0 PROXIMAL CONNECTOR SLEEVE. THE DISTAL TIP IS INTACT AND UNDAMAGED. DEVICE ANALYSIS CONFIRMS THE REASON FOR RETURN. PRODUCT SERVICE LIFE WAS APPROX 2 MONTHS.

    Description of Event or Problem · 1

    THE PT REPORTED A LOSS OF STIMULATION ON (B)(6) 2007. A LOSS OF EFFICACY DUE TO POSSIBLE WIRE FRACTURE WAS SUSPECTED. THE PRODUCT HAD BEEN PLACED IN (B)(6) 2006. THE DEVICE WAS EXPLANTED ON (B)(6) 2006 AND RETURNED TO THE MANUFACTURER FOR ANALYSIS AFTER TWO MONTHS IMPLANT DURATION. NO PT INJURY OR COMPLICATION HAS BEEN ATTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PISCES QUAD PLUS GZB MDT PUERTO RICO OPERATIONS CO., VILLALBA 3888 V001763

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other