BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2953462 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01106
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD WAS FOUND ON THE PROXIMAL AND DISTAL CONDUCTORS (NOT OBSTRUCTED). CONCOMITANT PRODUCTS: 4076 IMPLANTABLE PACING LEAD: (B)(6) 2012; 6947M IMPLANTABLE TACHY LEAD: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A COUPLE OF MONTHS, THE PATIENT EXPERIENCED THREE HEMATOMAS, ALL OF WHICH WERE EVACUATED. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE PROTRUDING THROUGH THE SKIN NEAR THE POCKET. THE SYSTEM WAS EXPLANTED, AND WILL BE REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A COUPLE OF MONTHS, THE PATIENT EXPERIENCED THREE HEMATOMAS, ALL OF WHICH WERE EVACUATED. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE PROTRUDING THROUGH THE SKIN NEAR THE POCKET. THE SYSTEM WAS EXPLANTED, AND WILL BEREPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56156 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R D314TRM IMPLANTABLE DEFIBRILLATOR