BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 3511450 · Received December 10, 2013

    Report

    Report Number
    3004209178-2013-22995
    Event Type
    Injury
    Date Received
    December 10, 2013
    Report Date
    September 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. CONCOMITANT MEDICAL PRODUCTS: 5076-52 IMPLANTABLE PACING LEAD 2006-02-13, 5076-58 IMPLANTABLE PACING LEAD, (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD UNACCEPTABLE THRESHOLDS. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IN ADDITION, THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE AN UPGRADE. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642502 SIGMA 300 DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SDR303B

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Hospitalization| R