BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2811662 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16395
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. SENSING/OVERSENSING: VENTRICULAR SHORT INTERVAL COUNT V-SIC=731.6 COUNTS AVG/DAY, IN 263 DAYS, BETWEEN (B)(6) 2011 13:02:52 AND (B)(6) 2012 13:16:07. IMPEDANCE/HIGH IMPEDANCE: WEEKLY PACE LEAD MEASUREMENT LOG DATA SHOW VARIOUS SPIKE INCREASES FOR MAX V. PACE = 784 TO 16382 OHMS RANGE BETWEEN (B)(6) 2011 AND (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THE PROXIMAL CONDUCTOR WAS FRACTURED, THE DEFIB CONDUCTOR WAS DISTORTED, AND THE DISTAL CONDUCTOR WAS STRETCHED. BLOOD/BODY FLUID WAS FOUND ON THE OUTER TUBING OVERLAY, WHICH WAS MELTED AND EXHIBITED COSMETIC ENVIRONMENTAL STRESS CRACKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS, AND THE LEAD EXHIBITED HIGH/VARYING IMPEDANCES. IT WAS SUSPECTED THAT THE LEAD HAD EXPERIENCED A SUBCLAVIAN CRUSH. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS, AND THE LEAD EXHIBITED HIGH/VARYING IMPEDANCES. IT WAS SUSPECTED THAT THE LEAD HAD EXPERIENCED A SUBCLAVIAN CRUSH. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB