BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1X8 TEST STIMULATION LEAD

    MDR report key: 1890228 · Received October 22, 2010

    Report

    Report Number
    6000153-2010-08329
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    VILLABA
    Product Code
    GZB
    PMA / PMN Number
    K051773
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE PLACEMENT OF THE LEAD INTO THE SNAP LID CONNECTOR, THE CONNECTOR LID WOULD NOT CLOSE. THE LEAD APPEARED TO BE BENT AT THE 6-7 CONTACT (IN SNAP LID). IMPEDANCE READINGS WERE ALL >10,000. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1X8 TEST STIMULATION LEAD GZB VILLABA 3873 V489674

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE PULSE GENERATOR: MODEL IPG, LOT# UNK| EXPLANTED:| STIM ACCESSORY: MODEL STYLET/RESTORE, LOT# UNK