BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN ABILITY

    MDR report key: 1730467 · Received June 22, 2010

    Report

    Report Number
    2649622-2010-06841
    Event Type
    Death
    Date Received
    June 22, 2010
    Date of Event
    May 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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) PROXIMAL CONDUCTOR FRACTURED, DISTAL AND DEFIB CONDUCTORS DISTORTED, BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER TUBING BUCKLED/KINKED AND INSULATION MELTED, OUTER TUBING OVERLAY MELTED AND BREACHED CUT, HELIX/LOBE DISTORTED/BENT, BLOOD IN/ON HELIX/LOBE MECHANISM. ANALYST COMMENT - THE BILUMEN TUBING VOID IS AT 59 CM. FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER EXTRACTION AND IMPLANTATION OF THE RV (RIGHT VENTRICULAR) AND LV (LEFT VENTRICULAR) LEADS, THE PATIENT ARRESTED AND DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER EXTRACTION AND IMPLANTATION OF THE RV (RIGHT VENTRICULAR) AND LV (LEFT VENTRICULAR) LEADS, THE PATIENT ARRESTED AND DIED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PHYSICIAN HAD FELT THE PATIENT WASN'T RECEIVING OPTIMAL CRT BENEFIT, SO OPTED TO TRY A DIFFERENT POSITION ON THE LV LEAD AND PROPHYLACTICALLY REPLACE THE RV LEAD. BOTH LEADS HAD BEEN FUNCTIONING FINE. THE LASER EXTRACTION PROCEDURE WENT FINE AS DID THE IMPLANTATION OF THE NEW LEADS. HOWEVER, PATIENT THEN BECAME COMBATIVE AND HAD A PRECIPITOUS DROP IN BLOOD PRESSURE. CPR WAS STARTED AND A PERICARDIOCENTESIS PERFORMED WITH A LITTLE BLOOD RETURNED. THE "HEART SURGEON OPENED THE PATIENT'S CHEST AND FOUND SOME TYPE OF VASCULAR TEAR THAT HAD OCCURRED DURING EXTRACTION THAT LED TO THE PATIENT DEATH." NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE SYSTEM RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER EXTRACTION AND IMPLANTATION OF THE RV (RIGHT VENTRICULAR) AND LV (LEFT VENTRICULAR) LEADS, THE PATIENT ARRESTED AND DIED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PHYSICIAN HAD FELT THE PATIENT WASN'T RECEIVING OPTIMAL CRT BENEFIT SO OPTED TO TRY A DIFFERENT POSITION ON THE LV LEAD AND PROPHYLACTICALLY REPLACE THE RV LEAD. BOTH LEADS HAD BEEN FUNCTIONING FINE. THE LASER EXTRACTION PROCEDURE WENT FINE AS DID THE IMPLANTATION OF THE NEW LEADS. HOWEVER, PATIENT THEN BECAME COMBATIVE AND HAD A PRECIPITOUS DROP IN BLOOD PRESSURE. CPR WAS STARTED AND A PERICARDIOCENTESIS PERFORMED WITH A LITTLE BLOOD RETURNED. THE "HEART SURGEON OPENED THE PATIENT'S CHEST AND FOUND SOME TYPE OF VASCULAR TEAR THAT HAD OCCURRED DURING EXTRACTION THAT LED TO THE PATIENT DEATH." NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE SYSTEM RELATED. THE PATIENT HAD NOT BEEN PACEMAKER DEPENDENT.

    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 Death 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB