BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1072207 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03890
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. EVALUATION SUMMARY: PRELIMINARY TESTING REVEALED NO OUTPUT, WHILE FUNCTIONAL TESTING REVEALED ANOMALOUS OUTPUT CONDITIONS. FURTHER TESTING REVEALED THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES.

    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: PRELIMINARY TESTING REVEALED NO OUTPUT, WHILE FUNCTIONAL TESTING REVEALED ANOMALOUS OUTPUT CONDITIONS. FURTHER TESTING REVEALED THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS CAPPED AND REPLACED DUE TO A FRACTURE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR DISPOSAL. IT WAS ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS CAPPED AND REPLACED, DUE TO A FRACTURE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR DISPOSAL. IT WAS ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION PROVIDED ALSO INDICATED THE LEAD WAS EXHIBITING UNDEFINED IMPEDANCE PRIOR TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention SDR303 IMPLANTABLE PULSE GENERATOR