BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 2203808 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04438
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    THE PATIENT STATED "I WOKE UP FEELING JUST TERRIBLE, I WAS SENT TO THE HOSPITAL, THEY CHECKED THE DEVICE OUT AND STATED THAT IT WASN'T WORKING AND THAT THE LEAD HAD FRAYED AND THAT I NEED TO HAVE IT REPLACED." THE FOLLOW-UP THAT WAS OBTAINED FROM THE CLINIC INDICATED THAT THE PATIENT CALLED THE CLINIC AND STATED [PATIENT] "HAD HAD A HEART ATTACK." A FOLLOW-UP VISIT WAS SCHEDULED, HOWEVER THE PATIENT DID NOT ATTEND. ADDITIONAL FOLLOW-UP OBTAINED FROM THE HOSPITAL INDICATES THAT THE PATIENT'S SYMPTOMS WERE RELATED TO A LEAD FRACTURE. THE LEAD AND THE DEVICE REMAIN 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
    1 MAXIMO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7232CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R