BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITY DDDR

    MDR report key: 1991197 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00250
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S4
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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: (B)(4) THE DEVICE WAS RETURNED TO THE LAB WITH NO OUTPUT AND NO TELEMETRY. DEVICE ANALYSIS FOUND 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 THERE WAS NO PACING, NO TELEMETRY, AND DIFFICULTY INTERROGATING THE DEVICE. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT PROPERLY RESPOND TO THE MAGNET TEST. THE DEVICE WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO PACING, NO TELEMETRY, AND DIFFICULTY INTERROGATING THE DEVICE. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT PROPERLY RESPOND TO THE MAGNET TEST. THE DEVICE WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARITY DDDR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 860 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD