BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3981800 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13989
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 14, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A COUPLING ISSUE. IT WAS NOTED THE PATIENT WAS ¿OUT OF¿ STIMULATION. IT WAS REPORTED THE PATIENT HAD TO REPOSITION THE ANTENNA SEVERAL TIMES TO CHARGE. IT WAS NOTED THE PATIENT HAD REVISION SURGERY FOLLOWING A CAR ACCIDENT TO ADDRESS COUPLING ISSUES. IT WAS REPORTED THE PATIENT¿S COUPLING WOULD GO FROM EIGHT TO FOUR TO ZERO BOXES. IT WAS NOTED BODY POSITION DID NOT AFFECT COUPLING. IT WAS REPORTED THE PATIENT DID NOT USE ADHESIVE STRIPS AS THEY WERE ALLERGIC TO ALL ADHESIVES. IT WAS NOTED THE PATIENT KEPT A THIN SHIRT BETWEEN THEIR BODY AND THE ANTENNA. IT WAS REPORTED THE PATIENT GOT HOT DURING RECHARGE AND WOULD SWEAT. IT WAS NOTED THE RECHARGER WOULD GET TOO HOT AND TIME-OUT DUE TO TEMPERATURE.

    Description of Event or Problem · 1

    THE PATIENT¿S HEALTH CARE PROVIDER (HCP) HAS NOT HEARD FROM THE PATIENT. IT WAS UNKNOWN HOW THE PATIENT WAS DOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458504 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 00035 YR Required Intervention