BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA VR

    MDR report key: 2951703 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01589
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 3, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5076, IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. INTERROGATION REVEALED POSSIBLE FAILURE OF WAVELET TO WITHOLD DETECTION DUE TO MATCH-SCORES BELOW THE PROGRAMMED THRESHOLD. THE DEVICE WAS REPROGRAMMED AND REMAINS 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
    57178 PROTECTA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| L| R 6947 IMPLANTABLE TACHY LEAD