BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2953595 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01219
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 4, 2012
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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: (B)(4). THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE HELIX WAS COMPRESSED. THE OUTER INSULATION WAS CUT. THE DISTAL AND PROXIMAL CONDUCTORS HAD BLOOD ON THEM (NOT OBSTRUCTED). THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THE DISTAL ELECTRODE WAS DAMAGED DUE TO OVERSTRESS. VISUAL ANALYSIS NOTED APPARENT EXPLANT DAMAGE. (B)(4). THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE PROXIMAL CONDUCTOR HAD BLOOD ON IT (NOT OBSTRUCTED). THE OUTER INSULATION HAD ENVIRONMENTAL STRESS CRACKING, A COSMETIC DEPRESSION AND WAS CUT. VISUAL ANALYSIS NOTED APPARENT EXPLANT DAMAGE. (B)(4). 6949 IMPLANTABLE TACHY LEAD 2007 (B)(6), 5568 IMPLANTABLE PACING LEAD 2007 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR LEAD FELL OUT DURING THE RA LEAD REVISION. BOTH LEADS WERE 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
    56168 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR