BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 1719109 · Received June 11, 2010

    Report

    Report Number
    2649622-2010-06770
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    April 21, 2010
    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
    TX, US
    Reporter Occupation
    HEALTH 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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 WERE FOUND. THE DISTAL SEGMENT WAS RETURNED AND ANALYZED. THE LEAD WAS RECEIVED WITH EXPLANT DAMAGE AND NO FRACTURE WAS OBSERVED. THE LEAD AND ALL CONDUCTORS WERE STRETCHED. BLOOD/BODY FLUID WAS PRESENT ON ALL CONDUCTORS. THE OUTER INSULATION WAS MELTED. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 WERE FOUND. THE DISTAL SEGMENT WAS RETURNED AND ANALYZED. THE LEAD WAS RECEIVED WITH EXPLANT DAMAGE AND NO FRACTURE WAS OBSERVED. THE LEAD AND ALL CONDUCTORS WERE STRETCHED. BLOOD/BODY FLUID WAS PRESENT ON ALL CONDUCTORS. THE OUTER INSULATION WAS MELTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD IMPEDANCE WAS HIGH, > 2500 OHMS. THE DEVICE WOULDN'T ALLOW THE LEAD TO GO TO TRUE BIPOLAR, AND THE IMPEDANCE HAS BEEN TRENDING UPWARD FOR MORE THAN TWO MONTHS. A MANUFACTURER TECHNICAL CONSULTANT SAID THIS IS CONSISTENT WITH A FRACTURE. IT WAS ALSO REPORTED THE LEAD WAS OCCLUDING ALL USEABLE VEINS. THE LEAD WAS EXPLANTED AND REPLACED WITH AN ADDITIONAL REPORT OF INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEFT VENTRICULAR LEAD IMPEDANCE WAS HIGH, > 2500 OHMS. DEVICE WON'T ALLOW THE LEAD TO GO TO TRUE BIPOLAR, AND THE IMPEDANCE HAS BEEN TRENDING UPWARD FOR MORE THAN TWO MONTHS. A MANUFACTURER TECHNICAL CONSULTANT SAID THIS IS CONSISTENT WITH A FRACTURE. IT WAS ALSO REPORTED THE LEAD WAS OCCLUDING ALL USEABLE VEINS. IT WAS FURTHER REPORTED THE SYSTEM WAS EXPLANTED DUE TO INFECTION, BUT FOLLOW-UP WITH THE NURSE REVEALED THERE WAS NO INFECTION AND THE LEAD SHOWED ELEVATED THRESHOLDS. LEAD WAS EXPLANTED AND REPLACED. LATER REVIEW OF THE MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED SIX WEEKS LATER. IT WAS REPORTED THAT SHE HAD BEEN ADMITTED TO THE ER WITH FLUID OVERLOAD AND WAS UNABLE TO BE RESUSCITATED AND DIED OF HEART FAILURE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    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 40 YR Death| R 4076-45 IMPLANTABLE PACING LEAD