BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III

    MDR report key: 5557849 · Received April 7, 2016

    Report

    Report Number
    9614453-2016-02625
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    February 5, 2016
    Report Date
    February 5, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Removal / Correction Number
    Z-0342-2016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: PRELIMINARY AND FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED DEVICE. RESULTS CONFIRMED NORMAL PACING AND SENSING FUNCTIONALITY. INTERNAL BATTERY IMPEDANCE DURING FUNCTIONAL TESTING WAS FOUND TO BE HIGHER THAN THE THRESHOLD ESTABLISHED FOR AUTOMATED TESTING. HOWEVER, THE MEASURED IMPEDANCE IN THE BATTERY HAD NOT REACHED A LEVEL TO IMPACT DEVICE PERFORMANCE. ADDITIONALLY, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. ELECTIVE REPLACEMENT INDICATOR (ERI) HAS NOT BEEN TRIGGERED AND THE BATTERY VOLTAGE WAS 2.96 VOLTS. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 4196-88 LEAD, IMPLANTED: (B)(6) 2009. (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 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS PROPHYLACTICALLY REPLACED. THE PATIENT IS PACING DEPENDENT, THEREFORE REPLACEMENT WAS INITIATED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214640 INSYNC III PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP IPG MFG SWITZERLAND 8042B

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R