BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2864894 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17561
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE LEAD INTEGRITY ALERT TRIGGERED ON 2012 (B)(6); POSITIVE FOR NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES AND ABNORMAL IMPEDANCE. THERE WAS AN OUT OF TOLERANCE SUBTHRESHOLD ALERT ON 2012 (B)(6) AND 2012 (B)(6). HIGH IMPEDANCE WAS NOTED. THE MAXIMUM VENTRICULAR PACE BIPOLAR IMPEDANCE ROSE FROM AN APPROXIMATE BASELINE OF 500 OHMS TO OVER 4000 OHMS THE WEEK OF 2012 (B)(6).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE AND WAS OVERSENSING. A REVIEW OF THE DEVICE PERFORMANCE DATA ALSO NOTED THAT A PATIENT ALERT TRIGGERED. THE LEAD WAS CAPPED 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
    1 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD)