BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 3992019 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14924
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. THE INITIAL REPORTED EVENT WAS RECEIVED ON 2014-04-28. OF NOTE, THE REPORTABLE ADVERSE EVENT (INFECTION ) IS NORMALLY SUBMITTED VIA A (B)(4) THAT WOULD HAVE BEEN SUBMITTED ON (B)(4) 2013. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(4) 2014 AND REVEALED THE DEVICE HAS TESTED OUT OF SPECIFICATION. THIS OUT OF SPECIFICATION FINDING DOES NOT QUALIFY FOR SUMMARY REPORTING AND IS THEREFORE BEING SUBMITTED AS A BIMONTHLY REPORT. PRODUCT EVENT SUMMARY: ANALYSIS INFORMATION -- PRODUCT ID# SEDR01 THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED A FRACTURED VENTRICULAR RING RIBBON WIRE AT THE HYBRID CONNECTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470078 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R 5568, 4076 LEADS