BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4250629 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21585
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 26, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# VA07GD1, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS IN A PROCEDURE TO BE IMPLANTED WITH A NEW IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENSIONS ON (B)(6) 2015 AFTER THE INFECTION FROM NOVEMBER HAD HEALED. IT WAS GOING TO BE PLACED IN THE ABDOMEN, BUT NO INS WAS PLACED NOR OPENED, AS THE SURGEON DID NOT GET THAT FAR. WHILE THE SURGEON WAS SHAVING THE PATIENT FOR THE NEW EXTENSION IMPLANT, THE SURGEON SAW A LESION OR SKIN TAG BEHIND THE RIGHT EAR AND OPENED THE AREA SURGICALLY AND SAID IT DID NOT LOOK GOOD. IT LOOKED LIKE THE INFECTION HAD MOVED UP FROM THE DEVICE POCKET TO THE EXTENSION PART THAT HAD NOT BEEN REMOVED. THE SURGEON THOUGHT THE PARTIAL REMOVAL OF THE EXTENSION WAS FINE AS IT HAD NOT APPEARED THE INFECTION HAD ADVANCED THAT FAR. THE SURGEON FELT HE MUST HAVE BEEN INCORRECT ABOUT THE INFECTION NOT BEING TO THE POINT OF THE EXTENSION. THE NEW EXTENSION SURGERY WAS NOT DONE AND NO NEW EXTENSIONS WERE OPENED OR USED. HOWEVER, THE SURGEON DID REMOVE THE PARTIAL LEFT IN EXTENSIONS AND CAPPED OFF THE LEADS. THE SURGEON THOUGHT HE MAY HAVE TO REMOVE THE LEADS DUE TO THE INFECTION AS WELL, BUT WANTED TO WAIT AND SEE IF THE ANTIBIOTICS PRESCRIBED WOULD HEAL THE INFECTION FIRST. MULTIPLE CULTURES WERE TAKEN AT THE EXTENSION SITE, BUT NO RESULTS WERE AVAILABLE YET.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT FELL AND BUMPED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AT TIMES AND THAT CREATED A SEROMA. THE INFECTION AT THE INS POCKET WAS DIAGNOSED ON (B)(6) 2014, BUT THE PATIENT HAD WAITED TWO WEEKS BEFORE NOTIFYING THEIR HEALTHCARE PROFESSIONAL (HCP). THE PATIENT HAD SYMPTOMS OF REDNESS, SWELLING, DRAINAGE, AND POCKET EROSION. THE PATIENT DID NOT HAVE MENINGITIS. A CULTURE OF THE DEVICE POCKET WAS OBTAINS AND STAPHOPI WAS CULTURED. ORAL ANTIBIOTICS AND A PARTIAL DEVICE SYSTEM EXPLANTED WERE REQUIRED. THE PATIENT'S INFECTION HAD RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE HAD BEEN EXPLANTED. NO OTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BOTTOM RIGHT CORNER OF THE POCKET WAS RED, SWOLLEN, AND THE SKIN HAD ¿ERUPTED¿ AND HAD A YELLOW DISCHARGE COMING OUT. THE DOCTOR STARTED THE PATIENT ON ANTIBIOTICS AND AN EXPLANT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENSIONS WAS PLANNED. THEY WERE GOING TO TRY AND PRESERVE THE LEADS IF POSSIBLE. IT WAS PLANNED FOR SOME TIME DURING THE WEEK AFTER REPORT. THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736969 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention