BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3222422 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11644
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DEVICE POCKET IRRITATION/INFECTION. THE ENTIRE SYSTEM WAS EXPLANTED AND DISPOSED OF "ACCORDING TO BIOHAZARD INSTRUCTIONS" ON THE DAY OF THE REPORT. DIAGNOSTIC METHODS INCLUDED EXAMINATION/PALPATION ON THE DAY OF THE REPORT. IT WAS STATED THAT THE EVENT WAS POSSIBLY RELATED TO THE DEVICE OR THERAPY AND TO IMPLANT PROCEDURE. THREE WEEKS LATER IT WAS REPORTED THAT THE POCKET SITE HAD ALSO BEEN PAINFUL. IT WAS STATED THAT THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON THE DAY OF THE EXPLANT. PRIOR TO THE EXPLANT REPROGRAMMING WAS ATTEMPTED TO SEE IF IT WOULD CHANGE "HOT FEELING." DEVICE INTERROGATION SHOWED NO PROBLEMS PRIOR TO THE EXPLANT. SIGNS/SYMPTOMS ALSO INCLUDED FEELING HEAT FROM THE DEVICE WHEN THE PATIENT TURNED IT ON AND FELT LIKE IT WAS GOING TO COME OUT OF THE POCKET. NUMBNESS AT THE SITE PRIOR TO THE EXPLANT WAS ALSO STATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323532 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 00038 YR Required Intervention