BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1875266 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11645
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    July 24, 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
    OH, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND IT WAS DISCOVERED THAT THE DISTAL CONDUCTOR WAS FRACTURED. THE OUTER INSULATION HAS COSMETIC DEPRESSION NEAR THE CONNECTOR. THE ANALYST NOTED THAT THE ANCHORING SLEEVE FIXATION SITE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD UNDEFINED RESISTANCE. IT WAS LATER REPORTED THAT THE LEFT VENTRICULAR LEAD'S SHOCK IMPEDANCES WERE OUT OF RANGE. THE LEFT VENTRICULAR LEAD WAS FRACTURED. THE LEFT VENTRICULAR LEAD WAS PARTIALLY EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD UNDEFINED RESISTANCE. THE LEFT VENTRICULAR LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE LEFT VENTRICULAR LEAD'S SHOCK IMPEDANCES WERE OUT OF RANGE AND FURTHERMORE, THERE WAS AN ALERT FOR SVC OUT OF RANGE IMPEDANCES. THE LEFT VENTRICULAR LEAD WAS FRACTURED. THE LEFT VENTRICULAR LEAD WAS PARTIALLY 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 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5071 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4592 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4592 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB