BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3160390 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10091
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    April 16, 2013
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES WERE FOUND. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND 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. PRODUCT ID: 694758, IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2008; PRODUCT ID: 4568 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM (ER) AFTER HEARING AN AUDIBLE ALERT TWICE AT FOUR HOUR INTERVAL. UPON INTERROGATION OF THE DEVICE, IT WAS NOTED THERE WAS AN INCREASED SHORT INTERVAL COUNTS (SIC) AND NON SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EVENT THAT WERE EITHER ELECTROMAGNETIC INTERFERENCE (EMI), NOISE OR OVERSENSING. FOLLOW UP CONFIRMED THE PATIENT HAD A LOOSE SET SCREW WHICH WAS CORRECTED DURING A REVISION. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THERE WAS UNDERSENSING OF VENTRICULAR FIBRILLATION (VF) AND A DECREASED SENSING WITH DEFIBRILLATION THRESHOLD TESTING (DFT). THE CUSTOMER SUSPECTED ISSUE WITH THE LEAD PIN AND SETSCREW INTERFACE. THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM (ER) AFTER HEARING AN AUDIBLE ALERT TWICE AT FOUR HOUR INTERVAL. UPON INTERROGATION OF THE DEVICE, IT WAS NOTED THERE WAS AN INCREASED SHORT INTERVAL COUNTS (SIC) AND NON SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EVENT THAT WERE EITHER ELECTROMAGNETIC INTERFERENCE (EMI), NOISE OR OVERSENSING. FOLLOW UP CONFIRMED THE PATIENT HAD A LOOSE SET SCREW WHICH WAS CORRECTED DURING A REVISION. THE DEVICE 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
    259944 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R