BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE LEAD

    MDR report key: 7362718 · Received March 22, 2018

    Report

    Report Number
    2124215-2018-05196
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    February 2, 2018
    Report Date
    June 25, 2019
    Manufacturer
    INTERMEDICS (GDT)
    Product Code
    DTB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THIS LEAD WAS RECEIVED AT OUR QUALITY ASSURANCE LABORATORY. THE SEGMENT OF LEAD WAS DECONTAMINATED AND FORWARDED FOR ANALYSIS; HOWEVER, THE SEGMENT WAS MISPLACED. AS OF TODAY, WE HAVE BEEN UNABLE TO LOCATE THE SEGMENT OF LEAD AND, THUS, HAVE BEEN UNABLE TO COMPLETE TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO HIGH PACING THRESHOLDS. MUSCLE STIMULATION WAS ALSO NOTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE HOSPITAL IS HOLDING ON TO THE SYSTEM THUS IT WILL NOT BE RETURNED AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO HIGH PACING THRESHOLDS. MUSCLE STIMULATION WAS ALSO NOTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204795 IMPLANTABLE LEAD IMPLANTABLE LEAD DTB INTERMEDICS (GDT) 431-02

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R 1283| 1297| 284-05| 4076| 431-02| 435-02| L321| MISMATCH| S606