BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PISCES QUAD PLUS

    MDR report key: 1800116 · Received August 11, 2010

    Report

    Report Number
    6000153-2010-06048
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 15, 2010
    Manufacturer
    MPROC, VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STYLETTE WAS CAUGHT IN THE LEAD, AND WHEN THE PHYSICIAN PULLED IT OUT, IT HAD DAMAGED THE LEAD. THE LEAD COULD NOT BE SALVAGED AS IT "FELL APART". THE LEAD WAS REPLACED PERIOPERATIVELY. IT WAS INDICATED THAT THE DAMAGED/REPLACED LEAD HAD NO IMPACT TOWARDS THE PT. 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 PISCES QUAD PLUS LGW MPROC, VILLALBA 3888 V488649

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL STYLET/STIM, LOT# UNK