BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1991135 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02263
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. FOR MODEL 5568. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. ADDITIONAL FINDINGS INCLUDE PROXIMAL CONDUCTOR DISTORTED, DISTAL CONDUCTOR FRACTURE (OVERSTRESS), OUTER INSULATION BREACHED CUT AND COSMETIC DEPRESSION, AND APPARENT EXPLANT DAMAGE. PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAD LOSS OF CAPTURE, HIGH IMPEDANCE, AND WAS APPARENTLY DISLODGED. THE RIGHT ATRIAL LEAD WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR LEAD HAD HIGH THRESHOLDS. THE LEFT VENTRICULAR LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5071 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD