BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3050995 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04784
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    January 30, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    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 ID 694765, IMPLANTED: (B)(6) 2008; PRODUCT ID D334TRG, IMPLANTED: (B)(6) 2012; PRODUCT ID ST-JUDE-LEAD, IMPLANTED: (B)(6) 2008.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFECTION WAS REPORTED. THE LEAD WAS REMOVED AND RETURNED TO THE MANUFACTURER. NO FURTHER PATIENT COMPLICATIONS HAVEBEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION. THE LEAD WAS REMOVED AND RETURNED TO THE MANUFACTURER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149216 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R