BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 200 DR

    MDR report key: 3862114 · Received June 10, 2014

    Report

    Report Number
    2647346-2014-00055
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-1516-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. CONCOMITANT PRODUCT: 407458 LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN A FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. PRELIMINARY ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TESTING REVEALED THAT THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MEASURED UNDEFINED IMPEDANCE AND LOSS OF CAPTURE ON THE ATRIAL AND VENTRICULAR CHANNELS. DURING THE REVISION PROCEDURE, THE DEVICE WAS REMOVED FROM THE POCKET AND THE LEADS WERE DISCONNECTED. MEASUREMENTS THROUGH THE DEVICE WERE UNDEFINED FOR THE ATRIAL AND VENTRICULAR VECTORS. THE LEADS, HOWEVER, MEASURED WITHIN NORMAL VALUES WHEN DISCONNECTED FROM THE DEVICE AND TESTED. THE DEVICE WAS EXPLANTED AND WAS REPLACED WHILE THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL AND VENTRICULAR LEADS EXHIBITED UNDEFINED IMPEDANCE AND LOSS OF CAPTURE. DURING THE REVISION PROCEDURE, THE DEVICE WAS REMOVED FROM THE POCKET AND THE LEADS WERE DISCONNECTED. MEASUREMENTS THROUGH THE DEVICE WERE UNDEFINED FOR THE ATRIAL AND VENTRICULAR VECTORS. THE LEADS MEASURED WITHIN NORMAL VALUES WHEN DISCONNECTED FROM THE DEVICE AND TESTED. THE DEVICE WAS EXPLANTED AND WAS REPLACED WHILE THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342595 SIGMA 200 DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MDT PUERTO RICO OPERATIONS CO, MED REL SDR203B

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR Hospitalization| R 457453 LEAD