BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2972578 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02955
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 5, 2013
    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

    PRODUCT ID, 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN INFECTION. THE REPORTER STATED THAT THE PATIENT HAD EXCELLENT RELIEF OF HIS PAIN UNTIL ABOUT TWO DAYS BEFORE THE REPORT. IT WAS STATED THAT THE PATIENT NOTICED SOME "WATERY AND PURULENT TINGES DRAINAGE" FROM HIS INCISION. IT WAS NOTED THAT THE PATIENT HAD A LOW-GRADE ELEVATED TEMPERATURE OF 100.8 DEGREES FAHRENHEIT. THE REPORTER STATED THAT THE PATIENT HAD "SIGNIFICANTLY INCREASED PAIN" OVER THE PAST TWO DAYS PRIOR TO THE REPORT AND WAS ADMITTED TO THE EMERGENCY ROOM WITH PURULENT DRAINAGE. IT WAS REPORTED THAT CULTURES WERE TAKEN OF THE INFECTED AREA WHICH SHOWED (B)(6). THE PATIENT'S SYSTEM WAS EXPLANTED. IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS ALIVE WITH NO INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A WOUND INFECTION AT THE IMPLANT SITE. DIAGNOSTIC METHODS INCLUDE LABORATORY TESTING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT LABORATORY TESTING SHOWED THAT THE CULTURES OBTAINED SHOWED GRAM-POSITIVE COCCI. IT WAS RECOMMENDED TO DO AN INCISION AND DRAINAGE WITH WASHOUT OF THE WOUNDS AND EXPLANT THE STIMULATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A WOUND INFECTION AT IMPLANTATION SITE. IT WAS NOTED THAT THERE WAS NO OTHER INFORMATION ABOUT THE INFECTION WAS AVAILABLE. IT WAS NOTED THAT THE EVENT REQUIRED IN-PATIENT HOSPITALIZATION. IT WAS NOTED THAT THERE WAS AN EMERGENCY ROOM VISIT. IT WAS NOTED THAT THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THAT CULTURES WERE TAKEN FROM THE PATIENT'S BACK EXUDATE SHOWING GRAM-POSITIVE COCCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76611 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 00041 YR Hospitalization| R