BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2790217 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02174
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Report Date
    November 12, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING - OVERSENSING 13 - VENTRICULAR NST<=210 MS ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 16:39:11 AND 16:58:49. 11 - VF<=210 MS AVERAGE V-CYCLE ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 16:11:21 AND 17:05:31. SENSING - INTERFERENCE/NOISE. VENTRICULAR SHORT INTERVAL COUNT V-SIC=1628.9 COUNTS AVG/DAY, IN 1.64 DAYS, BETWEEN (B)(6) 2012 20:22:19 AND (B)(6) 2012 11:40:52.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 80% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. IT WAS ALSO REPORTED THAT RIGHT VENTRICULAR (RV) LEAD HAD NOISE. DURING THE LEAD REPLACEMENT SURGERY NO NOISE WAS FOUND ON THE RV LEAD. THE PHYSICIAN SUSPECTED A CONNECTOR ISSUE WITH THE DEVICE AND THE DEVICE WAS REPLACED. AFTER THE DEVICE REPLACEMENT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO NOISE AND THE RV LEAD WAS ALSO REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND C174AWK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R