BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2052987 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05729
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    January 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE GUIDEWIRE WAS STUCK IN THE LEAD, THE LEAD APPEARED DAMAGE AT IMPLANT AND THE LEAD WAS STRETCHED. THE ANALYST NOTED THAT IT IS APPARENT THAT WHEN ATTEMPTING TO PULL BACK THE COMPETITOR GUIDEWIRE, ITS COATING BECAME ENSNARED WITH THE DISTAL CONDUCTOR. THIS CAUSED A DISTORTION OF THE FILARS AND DID NOT ALLOW THE COMPETITOR GUIDEWIRE TO BE REMOVED. THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD DISLODGED AFTER IMPLANT. THE PHYSICIAN PLANNED TO RE-IMPLANT THE LEAD, BUT DURING SURGERY FAILED TO INSERT THE GUIDE WIRE INTO THE LEAD. THE LEAD WAS REMOVED 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
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R