BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1920787 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12334
    Event Type
    Injury
    Date Received
    December 13, 2010
    Report Date
    February 27, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE AND LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR RECURRING PRESYNCOPE DUE TO UNDERSENSING. HIGH THRESHOLDS WERE NOTED ON THE RIGHT VENTRICULAR LEAD AND A LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS REPLACED. WHILE IN THE INTENSIVE THERAPY UNIT ON (B)(6) 2010 THE PATIENT EXPERIENCED LONG EPISODES OF SUDDEN ASYSTOLE WHICH REQUIRED RESUSCITATION. AT THIS TIME, THE DEVICE WAS CHANGED OUT DUE TO APPARENT UNDERSENSING. IT WAS ALSO REPORTED THAT THE "CORONARY SINUS" LEAD HAD "FAILURES". THE STATUS OF THE LEAD IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS WERE 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. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Hospitalization| R| O 1488T COMPETITOR IMPLANTABLE PACING LEAD| 1488T COMPETITOR IMPLANTABLE PACING LEAD