BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3833377 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09632
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3389S-28, LOT# VA0AU4E, IMPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3389S-28, LOT# VA0AU4E, IMPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37603, SERIAL# (B)(4),IMPLANTED: 2013-(B)(4), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389S-28, LOT# VA0AU4E, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. 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: 3389S-28, LOT# VA0AU4E, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3389S-28, LOT# VA0AU4E, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. 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 3389S-28, LOT# VA0AU4E, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3389S-28, LOT# VA0AU4E, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. 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 3389S-28, LOT# VA0AU4E, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THEY HAD RESCHEDULED TO (B)(6) FOR A NEW INS AND EXTENSION.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT HAD MET WITH THE HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2014 AND STILL HAD THE INFECTION. THE PATIENT WENT INTO THE OPERATING ROOM AND THE HCP REMOVED THE EXTENSION CONNECTOR AND LEFT THE LEAD IN PLACE WITHOUT A BOOT. IT WAS NOTED THAT THEY WERE WAITING FOR THE INFECTION TO RESOLVE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS AN INFECTION THAT WAS ATTRIBUTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS), LEAD AND EXTENSION. A MRI WAS PERFORMED ON (B)(6) 2014. MRI BRAIN READ AS NORMAL. THE PATIENT HAD REQUIRED HOSPITALIZATION AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. DIAGNOSIS OF INFECTION WAS ON (B)(6) 2014. IT WAS UNKNOWN IF THE PATIENT HAD MENINGITIS. SYMPTOMS OF INFECTION INCLUDED REDNESS, PAIN AND INCISIONAL WOUND OPENING. THE PRIMARY LOCATION OF THE INFECTION WAS THE RIGHT DEEP BRAIN STIMULATOR LEAD EXTENDER. IT WAS UNKNOWN IF A CULTURE WAS OBTAINED. INTRAVENOUS (IV) ANTIBIOTICS WERE ADMINISTERED AND THERE WAS A REVISION OF THE RIGHT LEAD EXTENDER. PATIENT OUTCOME WAS UNKNOWN; THE PATIENT WAS FOLLOWING UP WITH ANOTHER HEALTHCARE PROFESSIONAL FOR WOUND MANAGEMENT. IT WAS NOTED THAT MALNUTRITION AND THE PATIENT BEING EXTREMELY THIN WERE RISK FACTORS THAT APPLIED TO THE STATUS OF THE PATIENT BEFORE IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION. THE PATIENT WAS SEEN 1-2 DAYS PRIOR TO THE DATE OF THIS REPORT BY THE NEUROSURGEON. THE PATIENT HAD PRESENTED IN THE EMERGENCY ROOM ON THE DATE OF THIS REPORT. IT WAS NOTED THAT THERE WAS A POSSIBLE INFECTION ON ONE OF THE EXTENSIONS. IT WAS UNKNOWN WHICH EXTENSION. THE PATIENT WAS BEING TAKEN INTO SURGERY WHERE THEY PLANNED TO CLEAN IT OUT AND THEY WERE NOT PLANNING ON EXPLANTING ANY EQUIPMENT AT THAT TIME. IT WAS LATER REPORTED THAT THE PATIENT WAS IN THE OPERATING ROOM ON (B)(6) 2014 AND THE PATIENT WAS HAVING THE BATTERY AND EXTENSION REMOVED BECAUSE OF INFECTION. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENDER WERE EXPLANTED ON (B)(6) 2014. PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED ON ABOUT (B)(6) 2014. THE PATIENT DID NOT HAVE MENINGITIS. SIGNS AND SYMPTOMS OF INFECTION WERE FEVER AND SWELLING. THE PRIMARY LOCATION OF THE INFECTION WAS THE LEAD TRACK AND DEVICE POCKET. A CULTURE WAS OBTAINED FROM THE DEVICE POCKET AND THE TYPE OF ORGANISM WAS (B)(6). INTRAVENOUS (IV) ANTIBIOTICS WERE ADMINISTERED ALONG WITH ORAL ANTIBIOTICS AND PARTIAL EXPLANT FOR THE DEVICE SYSTEM FOR TREATMENT. PATIENT OUTCOME WAS ONGOING. IT WAS NOTED THAT RISK FACTS THAT APPLIED TO THE PATIENT PRIOR TO IMPLANT OF THE DEVICE INCLUDED DEBILITATED STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310881 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention