BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III

    MDR report key: 3993727 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01873
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT IS TIME FOR DEVICE REPLACEMENT. ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGERED ON (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 419388 LEAD, IMPLANTED: (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO A FALL AND INJURY THEY EXPERIENCED FROM SYNCOPE. IT WAS NOTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) FAILED TO PACE. IT WAS ALSO NOTED THAT THE DEVICE WAS BEING CHECKED MONTHLY DUE TO NEAR ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS. THE IPG 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
    472342 INSYNC III PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP IPG MFG SWITZERLAND 8042B

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R 1388T LEAD