BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2250677 · Received September 12, 2011

    Report

    Report Number
    3007566237-2011-07733
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE PT RECEIVED AN OCTAD LEAD CONNECTED DIRECTLY TO A PRIME ADVANCED AND FIXED WITH A TITAN ANCHOR. THE PT EXPERIENCED CHANGING PARESTHESIA AND AN X-RAY WAS TAKEN ON (B)(6) 2011. THE X-RAY CONFIRMED THAT THE LEAD HAD MIGRATED INFERIOR. THE LEAD WAS REVISED, THOUGH IT WAS UNCLEAR IF THE REVISION OCCURRED (B)(6) 2011 OR (B)(6) 2011. THE TITAN ANCHOR THAT WAS USED TO FIX THE LEAD WAS MANUFACTURED AFTER THE DESIGN ADJUSTMENT FOLLOWING THE FIELD ACTION OF (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# 0203880752| EXPLANTED:| IMPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| IMPLANTED: