BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC

    MDR report key: 4163402 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02455
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 438-35S-58, LEAD, IMPLANTED: (B)(6) 2005-08-29; PRODUCT ID: 2187-75, LEAD, IMPLANTED: (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RESET WAS BEING INDICATED DURING ROUTINE DEVICE CHECK. THE DEVICE WAS REPROGRAMMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643723 INSYNC PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP IPG MFG SWITZERLAND 8040

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR Required Intervention 432-35S-52 LEAD