BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3013297 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03989
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: EXTENSION: PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: EXTENSION: PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3998, LOT# J0405942V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED HE HAD INTERMITTENT STIMULATION AND IS CONCERNED HIS IMPLANTABLE NEUROSTIMULATOR (INS) MAY BE RUNNING OUT OF ENERGY. IT WAS STATED THAT THE PATIENT GOT "LESS THAN 50% THERAPY RELIEF." IT WAS NOTED THAT THE PATIENT'S INS STATUS READ "LOW" AND CAPACITY "88-100 USED; 2.2 VOLTS." IT WAS STATED THAT THE PATIENT ALSO HAD IMPEDANCE ISSUES WITH SEVERAL CONTACT COMBINATIONS. IT WAS NOTED THAT THE PATIENT WILL BE SEEING HIS PHYSICIAN AT A LATER DATE. IT WAS STATED THAT THE PATIENT'S STATUS IS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) DIED SINCE 2009 AND THEY HAVE BEEN TRYING TO LOCATE A HEALTHCARE PROFESSIONAL TO REPLACE THE INS. NO SYMPTOMS WERE REPORTED. RELEVANT MEDICAL HISTORY INCLUDES DEGENERATIVE DISC DISEASE/HERNIATED DISC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116354 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1