BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVO MRI SURESCAN

    MDR report key: 2965164 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02166
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 22, 2012
    Report Date
    December 22, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWP
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. FOREIGN MATERIAL WAS FOUND IN THE SETSCREW.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY AFTER IMPLANT, THE ATRIAL LEAD WAS FOUND TO HAVE DISLODGED. THE LEAD WAS REPOSITIONED, AND REMAINS IN USE. DURING THE REPOSITIONING PROCEDURE, THE PHYSICIAN ENCOUNTERED SIGNIFICANT DIFFICULTY IN SCREWING IN THE ATRIAL AND VENTRICULAR SETSCREWS. EVENTUALLY, THE PHYSICIAN WAS ABLE TO ENGAGE THE ATRIAL SETSCREW, BUT IT WAS NO LONGER POSSIBLE TO ADVANCE THE VENTRICULAR SETSCREW. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY AFTER IMPLANT, THE ATRIAL LEAD WAS FOUND TO HAVE DISLODGED. THE LEAD WAS REPOSITIONED, AND REMAINS INUSE. DURING THE REPOSITIONING PROCEDURE, THE PHYSICIAN ENCOUNTERED SIGNIFICANT DIFFICULTY IN SCREWING IN THE ATRIAL AND VENTRICULAR SETSCREWS. EVENTUALLY, THE PHYSICIAN WAS ABLE TO ENGAGE THE ATRIAL SETSCREW, BUT IT WAS NO LONGER POSSIBLE TO ADVANCE THE VENTRICULAR SETSCREW. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66848 REVO MRI SURESCAN PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MED REL MEDTRONIC PUERTO RICO RVDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R 5086MRI X2 IMPLANTABLE PACING LEADS