BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2830035 · Received November 13, 2012

    Report

    Report Number
    3007566237-2012-02701
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37081-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE EXTENSION MODEL 37081-40, SERIAL (B)(4) FOUND NO ANOMALY. IMPEDANCES WERE MEASURED WITH THE EXTENSION CONNECTED TO A KNOWN GOOD LEAD IN A 0.9% SALINE SOLUTION AND NORMAL IMPEDANCES WERE MEASURED ON ALL PAIRS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES MEASURED AFTER THE DEVICE IMPLANT PROCEDURE. THE REPORTER STATED THAT THE ELECTRODES ON CHANNEL 1 WERE "NOT OK" (PROBLEM WITH ELECTRODES 1, 2, 3, 4, 6 AND 7). THE REPORTER STATED THAT A NEW PROCEDURE WAS PLANNED AFTER THE FIRST TO REPAIR THE SYSTEM. IT WAS STATED THAT THE PADDLE LEAD AND EXTENSION 1 WERE RECONNECTED AND THE IMPEDANCES WERE STILL HIGH ON CHANNEL 1. THEN THE REPORTER STATED THE DEVICE POCKET WAS REOPENED AND THE EXTENSION WAS REMOVED AND REPLACED. AFTER THAT, IT WAS REPORTED THAT THE IMPEDANCES WERE CHECKED AND WERE "FINE." THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention