BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3884600 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11828
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# V323744, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# VA0FGE1, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 64002, LOT# N416573, PRODUCT TYPE: ADAPTER. PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3389S-40, LOT# V323744, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3389S-40, LOT# V323744, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# VA0FGE1, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389S-40, LOT# V323744, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# VA0FGE1, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 64002, LOT# N416573; PRODUCT TYPE ADAPTER PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V323744, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THERE WERE HIGH IMPEDANCES AND A POSSIBLE OPEN WAS DISCUSSED (B)(6). THERE WERE LOW IMPEDANCES AND SHORTS ON THE RIGHT LEAD. THE LOW IMPEDANCES WERE AT THE OPERATING ROOM VISIT. ALL COMBINATIONS OF OLD AND NEW ADAPTOR AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE TRIED WITH NO DIFFERENT OUTCOME. X-RAYS WERE DONE AND NOTHING APPARENT WAS SEEN. A POSSIBLE LEAD/EXTENSION CONNECTION ISSUE WAS DISCUSSED. THE PATIENT WAS PROGRAMMED ON THE LEFT AT 8-9-10- AND THE RIGHT AT C+12-13-15- WITH A PULSE WIDTH OF 100 AND AMPLITUDE OF 2.1. THE PATIENT HAD TREMOR AND HAD A LOSS OF 30% OF THE TREMOR CONTROL PLUS HAD THE SHOCKING PRIOR TO PUTTING INS IN. THE PATIENT WAS FAIRLY STABLE. THE PATIENT HAD SOME DEGREE OF SHOCKING PRIOR TO PROGRAMMING WHEN SHE HAD TURNED OFF AND CHANGED SETTINGS. THE LEAD FELT TOO DEEP AND ONCE THE LEADS WERE BROUGHT ANTERIOR THE ISSUES WITH SHOCKING WHEN PROGRAMMING HAD GONE AWAY. A SYSTEM ISSUE WAS DISCUSSED AND THERE WAS SPECULATION IT WAS AT THE LEAD/EXTENSION CONNECTION. THEY WERE GOING TO DO X-RAYS AGAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPLACEMENT SURGERY WENT WELL TO THE REPORTER'S KNOWLEDGE. IT WAS NOT SPECIFIED WHAT WAS DONE DURING THE SURGERY AND NO PATIENT OUTCOME WAS REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPORTER HAD ENGINEERS AND TECHNICAL SERVICES REVIEW THE IMPEDANCES AND THEY WERE ABLE TO REPLICATE THE IMPEDANCES WITH BENCH TESTING. THIS LED TO THE SCHEDULING OF AN X-RAY OF THE LEAD CONNECTION AND A CLINIC APPOINTMENT THE DAY AFTER THE REPORT.

    Description of Event or Problem · 1

    IMPEDANCES WERE STILL LOW ON HALF OF THE CONTACTS FOLLOWING A REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR AND ADAPTOR ON (B)(6) 2014. IT WAS NOTED THAT THEY WERE WAITING TO SCHEDULE ANOTHER SURGERY TO CHECK THE LEAD AND EXTENSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361022 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention