BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 5117688 · Received October 1, 2015

    Report

    Report Number
    3004209178-2015-19160
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 9, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION, PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT # V000574, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3487A-33, LOT # V001185, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THERE WERE OUT OF RANGE (OOR) IMPEDANCES WHEN TESTING AT 0.75V. THE FOLLOWING: 02, 04, 05, 06, 07, 12, 13, 14, 15 WERE OOR. IT WAS NOTED THAT THE REASON FOR THE INQUIRY WAS TO GET AN ESTIMATE ON BATTERY LIFE AS THEY WOULD BE REPLACING THE IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO NORMAL BATTERY CIRCUMSTANCES. SETTINGS PROVIDED WERE: 1, 5.0V, 360USEC, 75HZ. ON (B)(6) 2015, THE HCP REPORTED THAT THE OOR IMPEDANCES WERE DUE TO SOMEONE ENTERING THE NUMBERS IN THE CLINICIAN PROGRAMMER WRONG. ONCE IT WAS CORRECTED THERE WAS STILL 1 CONTACT THAT WAS OUT OF RANGE. IT WAS BELIEVED THAT CONTACT #1, BUT THE CAUSE FOR THIS WAS NOT DETERMINED. IT WAS THOUGHT EVERYTHING WAS RESOLVED AT THE TIME AND THERE WERE NO PATIENT SYMPTOMS OR FURTHER ISSUES NOTED. OTHER RELEVANT MEDICAL HISTORY INCLUDES FAILED BACK SURGERY SYNDROME. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT W ILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650334 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR