BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4860027 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-11996
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    May 26, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES WITH THE VALUE NOT SPECIFIED. THE DIAGNOSTIC TESTING AND TROUBLESHOOTING PERFORMED WAS IMPEDANCE TESTING AND X-RAYS. WHEN RECONNECTING THE LEAD, THE PHYSICIAN NOTICED THE SCREW ON THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS LOOSE. WHEN TIGHTENING THE SCREW, THE PHYSICIAN ALSO NOTICED THAT THE LEAD PORT WAS A LITTLE BIT TOO SHORT; THE LEAD DID NOT FIT PERFECTLY. THE SCREW WAS TIGHTENED AND IMPEDANCES WERE CHECKED. ALTHOUGH THE ELECTRODE SEVEN WAS NOT WORKING NOW, EVERYTHING ELSE WAS WORKING PERFECTLY AND FORTUNATELY THE PATIENT DID NOT NEED ELECTRODE SEVEN. EVERYTHING WAS NOW OKAY. THE PRODUCT ISSUE WAS RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404347 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention