BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2203290 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11850
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE HELIX FULLY EXTENDED, BLOOD AND TISSUE ON IT. BLOOD AND TISSUE ON THE HELIX FROM DISLODGEMENT CAUSED THE HELIX TO NOT RETRACT. ALSO HELIX WAS SLIGHTLY STRETCHED OUT OF SPECIFICATION, EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD DISLODGED AND THE HELIX ON THE LEAD WOULD NOT EXTEND OR RETRACT. THE LEAD WAS EXPLANTED 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 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5568 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R ADDRL1 IMPLANTABLE PULSE GENERATOR| 5092 IMPLANTABLE PACING LEAD