BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2862621 · Received December 10, 2012

    Report

    Report Number
    3007566237-2012-02943
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A DEVICE EXPLANTED ON (B)(6)-2012. THE REPORTER STATED THAT THERE WERE NO SYMPTOMS RELATED TO THE SITUATION AND NO TROUBLESHOOTING WAS DONE. NO PATIENT OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE MFR REPORT # 3004209178-2012-08383 IT WAS UNCLEAR IF THE SAME DEVICE SYSTEM WAS DESCRIBED IN BOTH REPORTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ENTIRE PADDLE LEAD COULD NOT BE REMOVED DURING AN INITIAL EXPLANT ON (B)(6) 2012. THE REPORTER STATED THAT THE REST OF THE LEAD WAS REMOVED ON (B)(6) 2012. DUE TO THE EARLIER REPORTED EXPLANT DATE OF (B)(6) 2012, IT WAS UNCLEAR WHICH DATE WAS CORRECT. THE EXPLANT ON (B)(6) 2012 WAS DESCRIBED IN MFR REPORT # 3004209178-2012-08383. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention