BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 6782065 · Received August 9, 2017

    Report

    Report Number
    2649622-2017-09121
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    May 8, 2017
    Report Date
    May 8, 2017
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2002; 6937-52 LEAD, IMPLANTED: 2000-07-14.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED A POCKET INFECTION AND THE DEVICE DID NOT DELIVER THERAPY DURING AN ARRHYTHMIA. THE PATIENT WAS RESCUED WITH AN EXTERNAL SHOCK. ADDITIONALLY, THE DEVICE COULD NOT BE INTERROGATED, DID NOT EMIT TONE WITH USE OF A MAGNET, AND DISPLAYED PREMATURE BATTERY DEPLETION. OF NOTE, INTERROGATION OF THE DEVICE THE PREVIOUS WEEK SHOWED NORMAL PARAMETERS AND DEVICE SHOCKS FOR VENTRICULAR FIBRILLATION. IT WAS ALSO REPORTED THAT DURING THE EXPLANT PROCEDURE OF THE DEVICE AND LEADS, IT WAS NOTED THERE WAS INSULATION DAMAGE OF THE FIFTY-TWO-CENTIMETER LEAD AND THE SIXTY-FIVE CENTIMETER LEAD BROKE DURING EXTRACTION FROM THE POCKET. BOTH LEADS WERE PARTIALLY REMOVED AND CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557382 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694265

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R