BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3952327 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13402
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 977A275, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A275, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN TODAY BY THEIR IMPLANTING PHYSICIAN WHERE IT WAS NOTED THAT THEY HAD 2 ¿PEA SIZED¿ OPEN AREAS WITH DRAINAGE AT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SITE WHICH WAS EXPOSING THE BATTERY. PATIENT SYMPTOMS OF PAIN, REDNESS, SWELLING, DRAINAGE, AND INCISIONAL WOUND OPENING WERE ALL REPORTED AT THE DEVICE POCKET SITE. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING HAD OCCURRED BUT WILL BE PERFORMED IN THE FUTURE. THE PATIENT¿S PHYSICIAN PLANNED ON EXPLANTING THE DEVICE (NEXT WEDNESDAY) AND TO START THE PATIENT ON ANTIBIOTICS. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS NOTED AS ¿ALIVE NO INJURY.¿ ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S LEADS AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE EXPLANTED ON (B)(6) 2014. NO NEW DEVICES WERE IMPLANTED AT THE TIME OF THE REPORT AND THE DEVICES WILL NOT BE RETURNED TO THE MANUFACTURE. THE MANUFACTURER REPRESENTATIVE WAS NOT AWARE OF ANY FURTHER ACTIONS OR OF A CONFIRMED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430568 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention