BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3754840 · Received April 16, 2014

    Report

    Report Number
    3004209178-2014-07391
    Event Type
    Injury
    Date Received
    April 16, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A-33, LOT# V821909, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 3487A-33, LOT# V759825, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION AFTER A DEVICE-RELATED PROCEDURE. THE HEALTH CARE PROVIDER REPORTED THAT THIS WAS "LOW GRADE AND BEHIND THE IMPLANTABLE NEUROSTIMULATOR (INS)." IT WAS NOTED THAT THE AREA WAS WARM TO THE TOUCH AND, AS OF APPROXIMATELY FIVE DAYS PRIOR TO REPORT, WAS NO LONGER BOTHERING THE PATIENT. ADDITIONAL INFORMATION RECEIVED THE FOLLOWING DAY REPORTED THAT THE PATIENT HAD A LOW GRADE FEVER AND HAD STARTED ON ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232711 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 00056 YR Required Intervention