BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2051266 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05530
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 28, 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
    PA, 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 NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED, THEIR OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THERE WAS APPARENT EXPLANT DAMAGE. ADDITIONALLY PERFORMANCE DATA WAS RECEIVED AND ANALYZED. FOURTEEN EPISODES OF NON-SUSTAINED VENTRICULAR TACHYCARDIA WITH AN AVERAGE CYCLE LENGTH OF <=210MS OCCURRED ON (B)(6) 2011 AND FOUR EPISODES OF VENTRICULAR FIBRILLATION WITH CYCLE LENGTH <=200 MS OCCURRED BETWEEN (B)(6) 2011 AND (B)(6) 2011. NOISE WAS NOTED AS VENTRICULAR SHORT INTERVAL COUNT WAS 704.6 COUNTS PER DAY BETWEEN (B)(6) 2011 AND (B)(6) 2011. TWO PATIENT ALERTS FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(6) 2011 AND (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD WHICH HAD BEEN CAPPED AT AN EARLIER PROCEDURE WAS UNABLE TO BE REACTIVATED DUE TO HIGH THRESHOLDS. THE LEAD WAS REMOVED AND REPLACED. THERE WAS NO FURTHER PATIENT COMPLICATIONS 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 68 YR Hospitalization| R (B)(4) IMPLANTAABLE ADAPTOR| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTAABLE ADAPTOR| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD