BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2811319 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16601
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    July 2, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THE OVERLAY TUBING HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND AN ENVIRONMENTAL STRESS CRACKING BREACH. THE OVERLAY TUBING HAD BLOOD INGRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT TRIGGERED FOR HIGH IMPEDANCE AND OVERSENSING. THE PATIENT DID RECEIVE MULTIPLE SHOCKS AND VENTRICULAR FIBRILLATION EPISODES WERE ALSO NOTED. THE LEAD WAS EXPLANTED 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 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD