BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1920856 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12345
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 24, 2010
    Report Date
    February 27, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND A COSMETIC DEPRESSION. THE LEAD WAS STRETCHED AND APPEARED TO HAVE EXPLANT DAMAGE. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE, THE 4193 LV LEAD COULD CAPTURE VIA THE ANALYZER BUT NOT AFTER HOOKING UP TO THE DEVICE. IN A LATER PROCEDURE, THE 4193 LEAD WAS EXPLANTED BECAUSE OF OBSERVED HIGH THRESHOLD RESULTING IN NO PACING CAPTURE. AN IMPLANT ATTEMPT WAS MADE TO REPLACE WITH A 4196 LEAD BUT THAT WAS UNSUCCESSFUL DUE TO CHALLENGES WITH THE PATIENT ANATOMY. AN EPICARDIAL LEAD WILL BE ATTEMPTED IN THE NEAR FUTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R| O 4035 COMPETITOR IMPLANTABLE PACING LEAD| 4064 COMPETITOR IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4035 COMPETITOR IMPLANTABLE PACING LEAD| 4064 COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB