BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVAIL S

    MDR report key: 3863062 · Received June 10, 2014

    Report

    Report Number
    2647346-2014-00047
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LWO
    PMA / PMN Number
    P850051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS OF THE RETURNED DEVICE WAS NOT PERFORMED BUT THE DEVICE MET THE EXPECTED LONGEVITY. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION AND EROSION OCCURRED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338630 PREVAIL S PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE LWO MDT PUERTO RICO OPERATIONS CO, MED REL 8086B

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R 4068 LEAD