BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2953213 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00955
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THERE WAS BLOOD ON THE PROXIMAL AND DISTAL PORTIONS OF THE LEAD (NOT OBSTRUCTED) AND BOTH THE PROXIMAL AND DISTAL CONDUCTORS WERE KINKED/BUCKLED AND PULLED/STRETCHED/OVERSTRESSED. THE LEAD WAS DAMAGED AN IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE GUIDEWIRE BECAME DIFFICULT TO PASS THROUGH THE LEFT VENTRICULAR LEAD DUE TO WHAT WAS POSSIBLY BLOOD COAGULATION IN THE LUMEN OF THE LEAD. THE PHYSICIAN FLUSHED THE LEAD, HOWEVER THE SAME ISSUE PERSISTED AND THE PHYSICIAN NOTED THERE MAY BE A MALFUNCTION OF THE LEAD TIP SEAL. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57710 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1