BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA VR

    MDR report key: 4163006 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19291
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RECEIVED WITH NO TELEMETRY. THERE IS NO DOCUMENTATION PROVIDEING ANY INFORMATION ABOUT THE SETTINGS THE DEVICE OPERATED UNDER AND THE PATIENT DID NOT FOLLOW UP FOR 33 MONTHS FOLLOWING IMPLANT. THE DEVICE LOST FUNCTION DUE TO BATTERY DEPLETION. WITH NO INFORMATION AVAILABLE THERE IS NO WAY TO DETERMINE IF THE BATTERY DEPLETED IN AN APPROPRIATE AMOUNT OF TIME.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NST (NON-SUSTAINED TACHYCARDIA) EVENTS WERE RECORDED WHILE THE PATIENT WAS IN THE HOSPITAL, PROMPTING A REQUEST FOR DEVICE INTERROGATION. THE DEVICE COULD NOT BE INTERROGATED, DESPITE USING TWO DIFFERENT PROGRAMMERS. A STETHOSCOPE WAS USED TO ACCESS ANY ALERT TONES COMING FROM THE DEVICE UPON THE TELEMETRY WAND BEING APPLIED, BUT NOTHING WAS HEARD. THE DEVICE WAS NOTED TO BE AT EOL (END OF LIFE). IT WAS ALSO NOTED THAT THE PATIENT HAD NOT BEEN SEEN BY THE PHYSICIAN SINCE IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639430 PROTECTA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R 694765 LEAD