BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2811936 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16643
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 25, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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) THE DEVICE WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. HIGH RESISTANCE IMPEDANCE: THERE WAS ONE PATIENT ALERT FOR OUT OF TOLERANCE (OOT) SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. PROGRAMMER DATA SHOWS ONE ALERT EVENT "RV DEFIBRILLATION LEAD IMPEDANCE > 200 OHMS" ON (B)(6) 2012. HIGH RESISTANCE IMPEDANCE: THERE WAS ONE PATIENT ALERT FOR OOT SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. PROGRAMMER DATA SHOWS ONE ALERT EVENT "SVC DEFIBRILLATION LEAD IMPEDANCE > 200 OHMS" ON (B)(6) 2012. HIGH RESISTANCE IMPEDANCE: THERE WAS ONE PATIENT ALERT FOR OOT SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. PROGRAMMER DATA SHOWS ONE ALERT EVENT "LV PACING LEAD IMPEDANCE > 3000 OHMS" ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PATIENT'S IN CLINIC VISIT AND UPON INTERROGATION THERE WAS AN IMPEDANCE CARE ALERT FOR THE LEFT VENTRICULAR (LV) LEAD. IT WAS ALSO REPORTED THAT THE ALERT STARTED THE DAY AFTER A ROUTINE DEVICE CHANGE OUT. IT WAS FURTHER REPORTED THAT THERE WAS NO CAPTURE ON THE LV LEAD AND AT CHANGE OUT AND THERE WAS AN OUT OF RANGE (OOR) IMPEDANCE, BUT WHICH IMPEDANCE AND UNDER WHAT CIRCUMSTANCE CANNOT BE RECALLED. THE LV LEAD REMAINS IN USE; HOWEVER, THE PHYSICIAN ELECTED TO CHANGE OUT THE NEW DEVICE DUE TO SUSPECTED SENSING ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4193

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD