BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 2951532 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01556
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    September 6, 2012
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.

    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). CONCOMITANT PRODUCTS: 5076-58 IMPLANTABLE PACING LEAD, (B)(6) 2001.-

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS INTERMITTENT LOSS OF CAPTURE WAS OBSERVED ON THE PACEMAKER. THE DEVICE 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
    55573 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO VEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Other