BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1921658 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12635
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND, HOWEVER THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED; PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIAPHRAGMATIC STIMULATION OCCURRED ON THE LEFT VENTRICULAR LEAD ON THE DAY OF IMPLANT, AND WAS CORRECTED BY REPROGRAMMING OF THE DEVICE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIAPHRAGMATIC STIMULATION OCCURRED ON THE LEFT VENTRICULAR LEAD ON THE DAY OF IMPLANT, AND WAS CORRECTED BY REPROGRAMMING OF THE DEVICE. IT WAS FURTHER REPORTED THAT THE PATIENT LIFTED HEAVY ITEMS AND THE LEAD PULLED BACK AND WAS CAUSING DIAPHRAGMATIC STIMULATION. DURING REPOSITIONING THE LEAD CAME OUT OF THE CORONARY SINUS. IT WAS SEEN ON THE VENOGRAM THAT THE VEIN WAS NOT PATENT. SINCE THE PATIENT HAD NOT SHOWN IMPROVEMENT WITH CARDIAC RESYNCHRONIZATION THERAPY (CRT) PACING, THE DECISION WAS MADE TO EXPLANT THE LEAD AND NOT REPLACE IT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O| R (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR