BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 4972135 · Received August 5, 2015

    Report

    Report Number
    3004209178-2015-15303
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    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
    NY, 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. CONCOMITANT MEDICAL PRODUCTS: 4024-58, LEAD AND 4568-53, LEAD, IMPLANTED:(B)(6) 1997. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIZZINESS, BRADYCARDIA AND PAUSES IN PACING. IT WAS INDICATED THAT A PREVIOUS IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI), TRIGGERING PACING AND INHIBITING THE CURRENTLY ACTIVE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD OF THE OLD IPG SYSTEM HAD INCONSISTENT CAPTURE. THE OLD DEVICE SYSTEM WAS PROGRAMMED OFF. IT WAS NOTED THAT "THE PATIENT WAS NO LONGER PACING FROM THE OLD DEVICE AND HER NEW DEVICE WAS FUNCTIONING NORMALLY WITH EXCELLENT THRESHOLDS. PHYSICIAN NOTIFIED AND INDICATED THAT HE PLANNED TO TAKE THE OLD DEVICE OUT." THE NEW DEVICE SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513520 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Hospitalization| R ADDRL1 IPG, 5076-52 LEAD, 5076-58 LEAD