BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTAD STANDARD LEAD 1X8

    MDR report key: 2220218 · Received August 16, 2011

    Report

    Report Number
    3007566237-2011-06441
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VERSITREL IMPLANTABLE PULSE GENERATOR (IPG) WITH A (B)(4) EXTENSION WAS RUNNING LOW ON BATTERY AND WAS REPLACED WITH A PRIME IPG WITH A (B)(4) EXTENSION. THE OCTAD LEAD WAS UNABLE TO BE INSERTED INTO THE NEW EXTENSION AND WAS DAMAGED. THE LEAD WAS REPLACED. THE PT WAS DOING FINE AND THE SYS WAS RUNNING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTAD STANDARD LEAD 1X8 LGW MEDTRONIC NEUROMODULATION 3877 B0325631K

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention EXTENSION: MODEL 37081, LOT# NJB092051V| EXPLANTED:| MODEL IPG, LOT# UNK| IMPLANTED:| EXPLANTED:| IMPLANTABLE PULSE GENERATOR:| IMPLANTED: