BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 2952766 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00707
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    March 27, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MPRI
    Product Code
    NVY
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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. PRODUCT EVENT SUMMARY THE FULL LEAD WAS RETURNED, ANALYZED, AND THE HELIX WAS DISTORTED AND BENT. IT WAS NOTED THAT THERE WAS BLOOD IN THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BODY ISSUE/FIBROTIC GROWTH IN THE DISTAL ELECTRODE, THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL WAS KINKED/BUCKLED, AND THERE WAS APPARENT EXPLANT DAMAGE. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2012, 4194 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD PULLED BACK AND WAS REPOSITIONED. TWO DAYS LATER THE LEAD HAD PULLED BACK AGAIN AND WHEN THE LEAD WAS REMOVED TO REPOSITION IT, THE HELIX WOULD NOT EXTEND. IT WAS NOTED THAT ON FLUOROSCOPY THE HELIX INDICATOR WAS FUNCTIONING. THE LEAD WAS EXPLANTED 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
    56022 DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES NVY MPRI 6947M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR