BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1X8 SUB COMPACT TEST STIMULATION LEAD

    MDR report key: 1971000 · Received January 6, 2011

    Report

    Report Number
    3007566237-2011-00109
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 10, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K051773
    Adverse Event
    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 F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    INFO RECEIVED STATED THE GUIDE WIRE BECAME STUCK IN THE LEAD WHILE INSERTED IN THE PT DURING THE PROCEDURE. WHEN THE PHYSICIAN TRIED TO REMOVE IT, THE WIRE SNAPPED IN TWO. THE LEAD HAD TO BE EXPLANTED AND A NEW LEAD KIT USED. PT IS SAID TO HAVE SUFFERED NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1X8 SUB COMPACT TEST STIMULATION LEAD GZB MEDTRONIC NEUROMODULATION 3876 0204447312

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL STYLET/STIM, LOT# UNK| IMPLANTED:| STIM ACCESSORY: MODEL STYLET/STIM, LOT# UNK| IMPLANTED:| STIM ACCESSORY: MODEL STYLET/STIM, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL STYLET/STIM, LOT# UNK| EXPLANTED:| STIM ACCESSORY: MODEL STYLET/STIM, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB005316V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB065316V| IMPLANTED:| IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL STYLET/STIM, LOT# UNK| STIM ACCESSORY: MODEL STYLET/STIM, LOT# UNK| IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL STYLET/STIM, LOT# UNK