BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1923238 · Received November 9, 2010

    Report

    Report Number
    3007566237-2010-09151
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A MFR'S REP REPORTED READING IMPEDANCES ">10000 OHMS" DURING IMPLANT. TWO LEADS HAD BEEN PLACED AND THE HEALTH CARE PROFESSIONAL WAS GOING TO TAKE ONE LEAD OUT AND REPLACE IT. NO PT SYMPTOMS WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK GZB MEDTRONIC NEUROMODULATION UNK LEAD_UNKN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# UNK