BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 3153088 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08875
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 1, 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
    DE, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED, THERE WERE NO ANOMALIES FOUND. CONCOMITANT MEDICAL PRODUCTS: 694765 IMPLANTABLE TACHY LEAD: (B)(6) 2009. 4076 IMPLANTABLE PACING LEAD: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WEEK AFTER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGE, THERE WAS AN ALERT FOR RIGHT VENTRICULAR (RV) LEAD IMPEDANCE OUT OF RANGE. THE POCKET WAS RE-OPENED, AND IT WAS FOUND THAT THE CHRONIC SUPERIOR VENA CAVA (SVC) COIL WAS NOT COMPLETELY SECURED IN THE HEADER OF THE ICD. UPON RECONNECTING THE DEVICE, THE COIL IMPEDANCE JUMPED TO A HIGH MEASUREMENT. BLOOD WAS REPORTED IN THE HEADER OF THE DEVICE. IT WAS ALSO NOTED THAT THERE MAY BE A SET SCREW ISSUE. THE ICD WAS EXPLANTED AND REPLACED; HOWEVER, THE RV LEAD EXHIBITED INTERMITTENT HIGH IMPEDANCE ON THE HIGH VOLTAGE (HV) COIL IMPEDANCE. DETECTIONS WERE TURNED OFF ON THE LEAD, AND A FEW DAYS LATER, THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255237 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| R