BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 54 CM

    MDR report key: 5511175 · Received March 18, 2016

    Report

    Report Number
    2183787-2016-00020
    Event Type
    Injury
    Date Received
    March 18, 2016
    Date of Event
    August 17, 2015
    Report Date
    February 24, 2016
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED AND EVALUATED. THE DEVICE HAD BEEN CUT INTO TWO PIECES WITH 60 CM AND 4.5 CM SEGMENTS. DC RESISTANCE AND HI-POT TESTING WERE UNABLE TO BE PERFORMED DUE TO THE DEVICE BEING CUT INTO TWO PIECES. THE CONNECTOR PIN, LARGE BOOT OUTER DIAMETER, AND HELIX HEIGHT ALL MET SPECIFICATION. THE LENGTH OF THE LEAD WAS OUT OF SPECIFICATION WITH THE TWO RETURNED PIECES MEASURING 64.5 CM WHILE SPECIFICATION IS 52.8 CM - 55.4 CM. THE INNER COIL WAS PULLED GIVING DEFORMATION AND COIL SEPARATION TO THE OUTER COIL WHICH IS ACCOUNTING FOR THE EXTRA LENGTH. VISUALLY THE SMALL SEAL HAS FM AROUND THE FIRST SEAL. THE LONGER SEGMENT OUTER TUBING HAS ABRASIONS, KINKS, AND DEFORMED COIL WITH FM INSIDE. THE SHORTER SEGMENT HAS A 3 MM LONG CUT IN THE OUTER TUBING. THE DONUT IS COVERED WITH FM. REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. ALL RECORDS INDICATE THE DEVICE MET SPECIFICATION PRIOR TO LEAVING GREATBATCH MEDICAL. RISK DOCUMENTATION WAS ALSO REVIEWED, HOWEVER, NO CONCLUSIONS COULD BE DRAWN SINCE THE MYOPORE LEAD IS IMPLANTED AS PART OF A COMPLEX PACING SYSTEM THEREFORE MAKING IT VERY DIFFICULT TO DETERMINE THE CAUSE OF THE PATIENT'S SYMPTOMS. IT MAY BE RELATED TO DEVICE MALFUNCTION, INHERENT PROCEDURAL COMPLICATION, PATIENT CONDITION OR ANATOMY, ETC. A ROOT CAUSE IS NOT ABLE TO BE DETERMINED AT THIS TIME. THE LEAD WAS BADLY DAMAGED SO ELECTRICAL TESTING COULD NOT BE PERFORMED TO DETERMINE IF THE LEAD WAS FUNCTIONING APPROPRIATELY. THE DEVICE IS PART OF SEVERAL IMPLANTED COMPONENTS THAT COMPRISE A PACING SYSTEM. GREATBATCH MEDICAL IS UNABLE TO DETERMINE IF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. ALL RECORDS INDICATE THE DEVICE MET SPECIFICATION PRIOR TO LEAVING GREATBATCH MEDICAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED RECURRENT EPISODES OF CHEST PAIN AND SHORTNESS OF BREATH POST IMPLANT AND REQUESTED THE SYSTEM TO BE REMOVED. NO CAUSE FOR HIS SYMPTOMS WOULD BE IDENTIFIED DESPITE EXTENSIVE WORKUP. THE SYSTEM WAS REMOVED (B)(6) 2015 AND THIS LEAD WAS CAPPED. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166162 MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 54 CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 511212 W2475587

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention