BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT RV

    MDR report key: 2904336 · Received January 9, 2013

    Report

    Report Number
    2649622-2013-00019
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL ELECTRODE WAS BENT. IT WAS NOTED THERE WAS BODY TISSUE ON THE DISTAL ELECTRODE, THERE WAS BLOOD ON THE DISTAL ELECTRODE AND THERE WAS APPARENT EXPLANT DAMAGE.

    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). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    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 RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED. DURING THE PROCEDURE TO REPOSITION THE RV LEAD THE HELIX REQUIRED MORE THAN 30 ROTATIONS TO EXTEND AND UPON REMOVAL OF THE LEAD TISSUE WAS NOTED ON THE HELIX. THE RV LEAD 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 RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED. DURING THE PROCEDURE TO REPOSITION THE RV LEAD THE HELIX REQUIRED MORE THAN 30 ROTATIONS TO EXTEND AND UPON REMOVAL OF THE LEAD TISSUE WAS NOTED ON THE HELIX. THE RV LEAD 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
    12371 SPRINT RV DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR Hospitalization| R IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR