BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 1851172 · Received September 30, 2010

    Report

    Report Number
    3007566237-2010-07499
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    April 14, 2010
    Report Date
    May 13, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AND INFECTION DURING A DEVICE TRIAL. THE PHYSICIAN STATED CONCERNS REGARDING SEVERAL INSTANCES OF INFECTIONS THAT HE BELIEVED WERE RELATED TO THE TRIAL LEADS. THE DEVICES WERE NOT RETURNED AND SEVERAL ATTEMPTS TO FOLLOW-UP WITH THE PHYSICIAN WERE UNSUCCESSFUL. THE LEAD WAS EXPLANTED FIVE DAYS AFTER THE TRIAL HAD STARTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL NEUROSTIMULATOR LGW MEDTRONIC NEUROMODULATION ENS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3874, LOT# V430841| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3874, LOT# V431292| LEAD: MODEL 3874, LOT# UNKNOWN| IMPLANTED: