BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC.SIGMA

    MDR report key: 2954893 · Received February 11, 2013

    Report

    Report Number
    2647346-2013-00015
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INTERROGATING THE DEVICE, RECEIVED MESSAGE OF BOTH ELECTIVE REPLACEMENT INDICATOR (ERI) AND POWER ON RESET (POR). IT WAS NOTED THAT DEVICE INTERROGATION CAN TRIP ERI IF BATTERY IS CLOSE TO CRITERIA, SINCE TELEMETRY CAN DRAIN THE BATTERY SOME. THE POR WAS CLEARED. THE DEVICE HAS BEEN 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
    58312 MEDTRONIC.SIGMA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MDT PUERTO RICO OPERATIONS CO, MED REL SSR303B

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention 507658 IMPLANTABLE PACING LEAD