BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1921581 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12606
    Event Type
    Injury
    Date Received
    December 13, 2010
    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
    MO, 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: (B)(4) NO ANOMALIES FOUND. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED AND THERE WAS APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLD AND THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION WHICH REQUIRED THE DEVICE TO BE REPROGRAMMED TO RIGHT VENTRICULAR PACING ONLY. THE LV LEAD WAS CAPPED, PARTIALLY EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE 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 60 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD