BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 1854991 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09181
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. ALL CONDUCTORS WERE DISTORTED, BLOOD/BODY FLUID WAS PRESENT, AND THERE WAS APPARENT IMPLANT DAMAGE. NO FRACTURE WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE LV (LEFT VENTRICULAR) LEAD PACING THRESHOLD WAS SATISFACTORY, UNTIL IT WAS SUTURED IN PLACE. AFTER BEING SUTURED IN PLACE, THE PACING THRESHOLD INCREASED FROM 0.6 TO 7 VOLTS. WHEN THE SUTURE WAS REMOVED TO REPOSITION THE LEAD, A POTENTIAL FRACTURE WAS NOTICED AT THE LOCATION OF THE SUTURE TIE DOWN. THE LEAD WAS REMOVED 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
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention