BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 5114663 · Received September 30, 2015

    Report

    Report Number
    3004209178-2015-19066
    Event Type
    Injury
    Date Received
    September 30, 2015
    Report Date
    September 8, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID 399960, LOT# V173511, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 3550-29, LOT# N536517, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THE DEVICE WAS EXPLANTED AND THE PATIENT CONTINUED ON ORAL ANTIBIOTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE (REP) THAT THEY HAD RECEIVED A VOICEMAIL FROM THE PHYSICIAN INDICATING AN INFECTION AT THE DEVICE POCKET THAT THEY HAD BEEN UNABLE TO CONTROL AND THAT THEY WOULD BE REMOVING THE DEVICE THE DAY AFTER THIS REPORT. RELEVANT MEDICAL HISTORY INCLUDES NON-MALIGNANT PAIN. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646315 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention