BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3803015 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08816
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-56, LOT# V091860, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3888-56, LOT# V091860, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 74002, LOT# N446458, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ADAPTER; PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WANTED TO KNOW IF THEIR MOST RECENT IMPLANT WAS MADE OF A DIFFERENT MATERIAL THAN THEIR FIRST ONE. THE REPORTER STATED THEY HAD A NEW IMPLANTABLE NEUROSTIMULATOR (INS) PUT IN ON (B)(6) 2014 AND IT HAD TO BE TAKEN OUT ON (B)(6) 2014 DUE TO AN INFECTION. THE REPORTER FURTHER STATED THEIR HEALTHCARE PROFESSIONAL (HCP) DID NOT KNOW WHAT TYPE OF INFECTION IT WAS. IT WAS NOTED THE PATIENT WANTED THEIR HCP TO PUT ANOTHER DEVICE IN, BUT THE HCP WANTED THEM TO GO THROUGH A TRIAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S SYSTEM WAS EXPLANTED AS PLANNED. IT WAS NOTED THAT THERE WAS A LOT OF FLUID IN THE POCKET WHEN IT WAS OPENED. IT WAS FURTHER NOTED THAT ONCE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED, INFECTION WAS FOUND UNDERNEATH THE INS SO THE ENTIRE SYSTEM INCLUDING THE LEADS WAS REMOVED. THE REPORTER STATED, THE POCKET WAS IRRIGATED WITH A LARGE AMOUNT OF ANTIBIOTIC SOLUTION. THE REPORTER FURTHER STATED, THEY FELT THIS MAY BE DUE TO THE PATIENT'S PRE-DIABETIC STATUS AND OBESITY SINCE THE PATIENT WAS IMPLANTED QUITE A WHILE AGO. IT WAS NOTED THAT CULTURES WERE TAKEN. IT WAS FURTHER NOTED THAT THERE WAS NO PLANT TO PUT ANOTHER SYSTEM IN THE PATIENT IN THE FUTURE. THE REPORTER STATED THE PATIENT WAS SENT TO A WOUND CENTER NEAR THEIR HOME FOR FOLLOW UP CARE AND MONITORING WHILE THEY HEAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO SYMPTOMS AT THE PATIENT'S POCKET. IT WAS NOTED THAT THE PATIENT'S POCKET WAS LOOKING RED, WAS WARM AND TENDER WITH THE PATIENT EXPERIENCING FEVERS. IT WAS NOTED THAT DURING THE EXPLANT, YELLOW AND WHITE PUS WAS SEEN. SEVERAL CULTURES WERE TAKEN DURING THE TIME, WHICH CAME BACK NEGATIVE. IT WAS NOTED THE PATIENT SAW THE PHYSICIAN ON (B)(6) 2014 DUE TO A FEVER AND PAIN IN THE POCKET. IT WAS NOTED THAT THE PATIENT WAS PRESCRIBED ANTIBIOTICS. IT WAS NOTED THAT THE PATIENT WAS SEEN ON (B)(6) 2014 AND THE INS WAS REMOVED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S ENTIRE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM WAS REMOVED TODAY BECAUSE OF A POTENTIAL INFECTION AT THE INS SITE. IT WAS ALSO REPORTED THAT THE INS SYSTEM WAS WORKING FINE AND DID NOT BELIEVE ANYTHING RELATED TO THE SYSTEM BUT WANTED TO REMOVE IT AS A PRECAUTION. IT WAS NOTED THAT THE SKIN WAS WARM TO THE TOUCH ALONG WITH INFLAMMATION AS WELL. IN ADDITION, IT WAS REPORTED THAT THERE WAS POSSIBLE FLUID ACCUMULATION AT THE SITE. THE PATIENT WAS DESCRIBED AS OVERWEIGHT AND THE DOCTOR HAD QUESTIONED SOME ¿DIABETIC TENDENCIES¿ TOWARD DIFFICULT HEALING. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281470 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention