BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2981389 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-03127
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    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 AN ELECTED IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY THE NEW INS WAS DISPLAYING IMPEDANCES THAT WERE OUT OF RANGE. ALL IMPEDANCES ON CHANNEL #2 SHOWED IMPEDANCES GREATER THAN 40 ,000 OHMS AT 3.0 V. IT WAS STATED THAT PRE-OPERATION THE PATIENT'S INS SHOWED NORMAL IMPEDANCES AT 0.7 V. THE PATIENT HAD NOT REPORTED ANY ISSUES WITH THE STIMULATOR PRIOR TO GOING INTO SURGERY. THE NEW INS WAS ATTACHED TO THE LEADS AND THEY TESTED THE IMPEDANCES. AT 0.7V ELECTRODES 8-15 WERE ALL OUT OF RANGE. THE TEST WAS RE-RAN AT 3.0V AND ELECTRODE 8-15 WERE STILL OUT OF RANGE. THE LEADS WERE REMOVED AND CLEANED OFF AND THE TEST WAS RUN AGAIN. THEN THE LEADS WERE SWITCHED TO SEE IF IT WAS THE EXTENSION OR THE INS CHANNEL. WHEN THAT TEST WAS RUN, ELECTRODES 0-7 AND 8-15 WERE OUT OF RANGE. BEFORE THE SECOND INS WAS OPENED THE IMPEDANCES WERE TESTED WITH THE ORIGINAL INS AND THE IMPEDANCES WERE THE SAME AS THEY WERE PRIOR TO SURGERY. THIS CONCLUDED THAT THE LEADS WERE "BEHAVING NORMALLY". THIS INS WAS NOT USED IN THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY OR ADVERSE EVENT. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85401 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1