BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1820561 · Received August 31, 2010

    Report

    Report Number
    2182208-2010-00608
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    July 9, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    K911827
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND; FULL LEAD WAS RETURNED FOR ANALYSIS. THE SETSCREW WAS OBSTRUCTING THE BORE AND THE SETSCREW WRENCH WAS BROKEN OFF IN SETSCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS UNACCEPTABLE THRESHOLDS, NO CAPTURE AT MAXIMUM OUTPUTS, IMPEDANCE WAS GREATER THAN 10,000 OHMS, AND THAT THE EXTENSION LEAD HAD DETACHED FROM ORIGINAL EPICARDIAL PACING LEAD. IT WAS FURTHER REPORTED THAT THE PHYSICIAN HAD DIFFICULTY ATTACHING THE EXTENSION LEAD. THE LEAD HAS BEEN 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 NONE PERMANENT LEAD EXTENSION DTB MEDTRONIC, INC. 6981M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR