BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3821337 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09275
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 30, 2014
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD PRODUCT ID: NEU_ RECHARGER_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE (REP) RAN AN ELECTRODE IMPEDANCE TEST AND ALL ELECTRODES CAME UP WITH THREE XXX'S ON THE FIRST IMPEDANCE TEST. ADDITIONAL TESTS WERE RUN AT 0.7 VOLTS AND IMPEDANCES WERE FINE. IT WAS NOTED THAT ONLY 0-7 WERE OUT OF RANGE AND SHOWED GREATER THAN 10,000 BUT THIS HAD BEEN A KNOWN ISSUE SINCE AROUND THE TIME THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED BECAUSE THEY OPTED TO NOT FIX IT AT THE REPLACEMENT PROCEDURE. IT WAS NOTED THE PATIENT WAS FEELING STIMULATION AS INTENDED AND THERE WAS NO LOSS OF THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS LOOSE IN THE POCKET AND MAY HAVE FLIPPED. ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURING REPRESENTATIVE WAS SEEING THE PATIENT ON WEDNESDAY. ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT LAST WEEK. IT WAS NOTED THAT IMPEDANCES WERE CHECKED AND ALL IMPEDANCES WERE GREATER THAN 10,000 OHMS. IT WAS FURTHER NOTED THE PATIENT HAD A LACK OF THERAPY. THE REPORTER STATED THE PATIENT DID NOT WANT FURTHER SURGERY AND THERE WAS NO OTHER INTERVENTIONS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300174 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 00059 YR