BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1925228 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13758
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: (B)(4): A PARTIAL LEAD IN SEGMENTS WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. THE DEFIB CONDUCTOR WAS DISTORTED AND FRACTURED DUE TO OVERSTRESS. THE OUTER TUBING OVERLAY WAS MELTED. THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKS, IT HAD A COSMETIC DEPRESSION, AND THERE WAS A WHITE SUBSTANCE PRESENT ON IT. THERE WAS ALSO A WHITE SUBSTANCE ON THE EXPOSED DEFIB COIL. THERE WAS APPARENT EXPLANT DAMAGE. WE ALSO RECEIVED PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS RESULTS REVEALED HIGH RESISTANCE/IMPEDANCE. A RIGHT VENTRICULAR PACE LEAD IMPEDANCE PATIENT ALERT WAS RECORDED ON (B)(6) 2010. VENTRICULAR PACE LEAD IMPEDANCE RISES FROM AN APPROXIMATE BASELINE OF 750 OHMS THE WEEK OF (B)(6) 2010 TO A HIGH OF 9008 OHMS THE WEEK OF (B)(6) 2010.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXPERIENCED HIGH IMPEDANCE, AND HIGH THRESHOLD. IN ADDITION, APPARENT LEAD FRACTURE WAS OBSERVED ON FLUOROSCOPE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB