BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 3993693 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09183
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. CONCOMITANT MEDICAL PRODUCTS: 694758 LEAD, IMPLANTED: (B)(6) 2004; 407645 LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4): THE (B)(4) LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE LV (LEFT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE AND ANALYSIS OF THE DEVICE MEMORY INDICATED A LEAD IMPEDANCE OUT OF RANGE ALERT.

    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 THE RIGHT VENTRICULAR (RV) AND SUPERIOR VENA CAVA (SVC) IMPEDANCES HAVE RISEN. THE LEFT VENTRICULAR (LV) LEAD IMPEDANCE ALSO ROSE AT THE SAME TIME AS THE RV AND SVC DID. THE RV LEAD HAS A POSSIBLE FRACTURE AND IT WAS CAPPED AND A NEW SINGLECOIL LEAD WAS IMPLANTED. THE LV 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
    472139 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419378

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR D224TRK ICD