BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2053597 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05942
    Event Type
    Injury
    Date Received
    April 13, 2011
    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
    TN, 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): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. MAX SVC LEAD IMPEDANCE RISES FROM AN APPROXIMATE BASELINE OF 70 OHMS THE WEEK OF (B)(6) 2010 TO A HIGH OF 13192 OHMS THE WEEK OF (B)(6) 2010. V PACE LEAD IMPEDANCE RISES ABRUPTLY FROM 944 OHMS THE WEEK OF (B)(6) 2010 TO 16382 OHMS THE REMAINING WEEKS OF THE RECORD. MAX SVC LEAD IMPEDANCE VARIES BETWEEN BASELINE AND HIGH VALUE (13192 OHMS) ERRATICALLY OVER THE WEEKS BETWEEN (B)(6) 2010 AND EXPLANT. MULTIPLE SHORT V-V SENSED EVENTS OF < 220 MS ARE OBSERVED ON THE (B)(6) 2010. (47 EPISODES NST (NON-SUSTAINED TACHYCARDIA), 4 EPISODES VF (VENTRICULAR FIBRILLATION)) HIGH V-SIC (SHORT INTERVAL COUNT) OBSERVED WITH 35360 COUNTS ON THE LIFETIME COUNTER, THE BULK OF THESE COUNTS OCCURRING SINCE THE (B)(6) 2010. HIGH SIC CAN INDICATE THE PRESENCE OF NOISE OR INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD FRACTURED, WAS OVERSENSING AND HAD HIGH IMPEDANCE. 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 75 YR Hospitalization| R 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB