BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3870526 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11511
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    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) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICE MET RISK BASED CRITERIA.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HEMATOMA. THE PATIENT WENT TO THE EMERGENCY ROOM ON THE DAY OF THE REPORT. THE DOCTOR WANTED INFORMATION ON MRIS OF THE SPINE FOR A POSSIBLE EPIDURAL HEMATOMA. IT WAS UNKNOWN IF THE ISSUE WAS RELATED TO THE DEVICE. IT WAS FURTHER REPORTED THAT A HEMATOMA WAS SUSPECTED AND CT SCANS AND MRIS WERE ORDERED. A SMALL UNKNOWN FLUID COLLECTION BY THE SPINE WAS NOTICED. THE PATIENT WAS SUBSEQUENTLY PUT ON MEDICATIONS. THE PATIENT WAS SEEN AGAIN ON (B)(6). AT THAT POINT IT WAS STILL CONSIDERED A SMALL HEMATOMA AND LESS OF AN INFECTION. THE DOCTOR THOUGHT THAT EVERYTHING WAS UNRELATED TO THE SPINAL CORD STIMULATOR DEVICE BUT THEY COULD NOT CONFIRM SINCE THEY DID NOT HANDLE THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AN EXPLANT WAS PLANNED FOR 2014-(B)(6). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE EXPLANT WAS DONE BECAUSE THE PATIENT REQUESTED IT. THE LEADS AND STIMULATOR WERE EXPLANTED. THE PATIENT WAS DOING FINE AT THE TIME OF THE REPORT AND THEY RECOVERED FROM THE EXPLANT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELAE. THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348477 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention