BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 2051106 · Received April 12, 2011

    Report

    Report Number
    6000144-2011-01504
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND. SERIAL NUMBER WAS LIKELY ACCIDENTALLY CLEARED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE APPEARED TO HAVE HAD A POWER ON RESET WHEN THE DATA FROM A CARELINK TRANSMISSION WAS REVIEWED. UPON FURTHER REVIEW OF A SAVE-TO-DISK FROM THE DEVICE IT WAS DETERMINED THAT A POR HAD NOT OCCURRED AND THE DEVICE SERIAL NUMBERS WERE INADVERTENTLY CLEARED AT THE TIME OF IMPLANT WHICH RESULTED IN THE LATER CARELINK TRANSMISSION RECEIVING AN ERROR MESSAGE. THE DEVICE INFORMATION FOR THE PATIENT WAS REENTERED AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention (B)(4) IMPLANTABLE PACING LEADS