BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3991406 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08149
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT: 407652 LEAD 2004-(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY- A MEDIAL PORTION OF THE LEAD WAS RECEIVED MEASURING 6.5 CM. A DISTAL PORTION WAS RECEIVED MEASURING 6 CM. THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. ANALYSIS INFORMATION -- 2014 (B)(6) 14:21:23 CST PLI# 10 PRODUCT ID# 694765, A MEDIAL PORTION WAS RECEIVED MEASURING 6.5 CM. A DISTAL PORTION WAS RECEIVED MEASURING 6 CM. THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO, ANALYSIS INFORMATION -- 2014 (B)(6) 23:06:18 CST PLI# 20 PRODUCT ID# D154AWG, THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND, PRODUCT ID D154AWG, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2014 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT HELICAL SCREWS ON THE RV LEAD WERE RETRACTED HOWEVER, THE LEAD COULD NOT BE REMOVED WITH MANUAL TRACTION ALONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS AS A RESULT OF A RIGHT VENTRICULAR (RV) LEAD FRACTURE. IT WAS ALSO REPORTED THAT AT TIMES DURING THE LEAD FRACTURE THE PACE SENSE PORTION WAS UNABLE TO CAPTURE, THERE WAS HIGH IMPEDANCE AND NOISE. THE LEAD WAS PROGRAMMED OFF. IT WAS LATER REPORTED THAT 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
    470008 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| L| R (B)(4) ICD