BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2991601 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03406
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE STIMULATOR REVEALED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEAD IMPLANTING PROCEDURE, THE IMPLANTING PHYSICIAN COULD NOT GET A NEW LEAD TO GO INTO THE PLUG WITHOUT FORCE. WHEN IT WAS PLUGGED IN, IMPEDANCE ISSUES WERE NOTED ON CLINICIAN PROGRAMMER. IT WAS ELECTED TO IMPLANT A NEW NEUROSTIMULATOR AND THE NEW LEAD WAS PLUGGED INTO THE SITE WITHOUT ISSUES. PATIENT STATUS AT THE TIME OF THIS REPORT WAS STATED AS ALIVE WITH NO INJURY/NO ADVERSE EVENT. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94689 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR