BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 3993379 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09356
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 5071-53 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEADS HAD HIGH THRESHOLDS. THE LEADS HAD BEEN ADAPTED AT IMPLANT, WITH ACCEPTABLE BIPOLAR THRESHOLDS AT IMPLANT AND AT THE POST OPERATIVE CHECK THE FOLLOWING DAY; HOWEVER, THE THRESHOLDS SUBSEQUENTLY ROSE. THE PHYSICIAN ATTEMPTED TO REVISE THE LEADS WITH THE ADAPTER, BUT BOTH LEADS CONTINUED TO EXPERIENCE HIGH THRESHOLDS. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED TEMPORARY LOSS PACING AND REQUIRED A TEMPORARY WIRE. BOTH EPICARDIAL RV LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470864 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R ADDR01 IPG