BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD-2

    MDR report key: 2131580 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10663
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MPRI
    Product Code
    DXY
    PMA / PMN Number
    P890003/S50
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS A PARTICIPANT IN THE SHOCK-LESS STUDY (SLS). CONCOMITANT PRODUCTS: ADDRL1 IMPLANTABLE PULSE GENERATOR (B)(6) 2009; 5568-53 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    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.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC COMPLAINING OF PRE-SYNCOPAL AND DIZZY SPELLS. UPON INTERROGATION, THE VENTRICULAR LEAD HAD UNDEFINED IMPEDANCE IN BIPOLAR CONFIGURATION. THRESHOLDS WERE POOR IN BIPOLAR AND DID NOT CAPTURE EVEN AT HIGH AMPLITUDE. THE LEAD WAS REPROGRAMMED TO UNIPOLAR AND APPROPRIATE SAFETY MARGINS WERE PROGRAMMED. THE LEAD REMAINS IN USE UNTIL A LEAD REVISION CAN BE PERFORMED. THE PATIENT IS A PARTICIPANT IN THE SHOCK-LESS STUDY (SLS). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS OVERSENSING AND A POSSIBLE LEAD FRACTURE WAS SEEN ON XRAY. THE LEAD WAS ELECTRONICALLY ABANDONED, BUT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE VDD-2 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MPRI 5038 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R