BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3983265 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14007
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 977A275, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A275, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (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; PRODUCT ID 977A275, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A275, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN UNKNOWN TYPE OF INFECTION. THE ONSET OF THE INFECTION WAS A LITTLE OVER A WEEK PRIOR TO THE REPORT AND WAS LOCATED AROUND THE DEVICE POCKET AND LEAD LOCATION. THERE WAS A CULTURE TAKEN AND ANTIBIOTICS WERE GIVEN TO THE PATIENT; THE RESULTS OF THE CULTURE WERE NOT SPECIFIED. IT WAS FURTHER REPORTED THE WHOLE SYSTEM WAS EXPLANTED ABOUT A MONTH AFTER IMPLANT DUE TO DEVICE POCKET BEING INFECTED. THE DEVICE WILL BE REPLACED IN THE FUTURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INFECTION RESOLVED. THE PATIENT HAD A REFERRAL TO A DIFFERENT SURGEON FOR REIMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS UNDETERMINED BUT WAS DEVICE RELATED. THE ENTIRE SYSTEM WAS REMOVED AND THE PATIENT OUTCOME WAS UNKNOWN DUE TO BEING SO SOON AFTER IMPLANT. NO PATIENT OUTCOME WAS PROVIDED HOWEVER ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW-UP REPORT WILL BE WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459649 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention