BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3922445 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12707
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PRIMARY SITE OF THE INFECTION WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT¿S PHYSICIAN DID OBTAIN CULTURES FROM BOTH INCISIONS (THE SITE OF THE IMPLANTABLE NEUROSTIMULATOR BATTERY POCKET AND THE LEAD SITE) BUT THE CULTURE RESULTS WERE UNKNOWN. IT WAS REPORTED THAT THE PATIENT DID RECOVER WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE ALSO MANUFACTURER¿S REPORT # 3004209178-2014-12705 FOR PATIENT¿S OTHER DEVICE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION FOLLOWING A LEAD REVISION ¿A FEW WEEKS¿ PRIOR TO REPORT (SEE EVENT 700649516 ¿ THESE EVENTS ARE NOT RELATED). IT WAS NOTED ON DAY OF THE CALL THE PATIENT WENT TO THE ER AND THEN DIRECTLY TO THEIR HEALTH CARE PROVIDER (HCP). IT WAS NOTED THE PATIENT¿S HCP DETERMINED ¿IT¿ WAS INFECTED AND ALL THEIR COMPONENTS WERE EXPLANTED. IT WAS NOTED AFTER THE LEAD REVISION THE PATIENT HAD ASKED THEIR HCP HOW SOON THEY COULD GO SWIMMING AFTER REVISION AND HCP SUSPECTS PATIENT MAY HAVE GONE SWIMMING TOO SOON AFTER THEIR LEAD REVISION HOWEVER THIS WAS NOT CONFIRMED. IT WAS REPORTED THE HCP IS UNSURE IF THEY WILL RE-IMPLANT OR NOT. SUSPECTED SYMPTOMS WERE REPORTED TO HAVE BEEN REDNESS AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399934 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention