BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1720687 · Received June 11, 2010

    Report

    Report Number
    2649622-2010-05359
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    January 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. (B)(4) NO ANOMALIES FOUND, SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED). PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, PROXIMAL CONDUCTOR STRETCHED, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT 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.

    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. (B)(4) NO ANOMALIES FOUND, SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED). PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, PROXIMAL CONDUCTOR STRETCHED, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT, WITH A COMPLEX MEDICAL HISTORY WAS ADMITTED TO THE HOSPITAL WITH RESPIRATORY FAILURE. THE PATIENT WAS FOUND TO BE SEPTIC, WITH FEVER. HE WAS TRANSFERRED TO ICU AND WAS ON VENTILATOR SUPPORT. THE SOURCE OF THE INFECTION COULD NOT BE IDENTIFIED. THE PATIENT WAS POSITIVE FOR (B)(6). HE ALSO HAD 'BOUTS' OF SINUS TACHYCARDIA AND ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. HE ALSO HAD MULTIPLE SHORT BURSTS OF VENTRICULAR TACHYCARDIA BUT WAS ASYMPTOMATIC AND WAS GIVEN RATE CONTROL MEDICATIONS. AFTER 18 DAYS, PATIENT WAS TAKEN OFF THE VENTILATOR, AND ONE WEEK LATER ((B)(6) 2010) HE WAS DISCHARGED TO A SKILLED NURSING FACILITY IN STABLE CONDITION. IT WAS LATER REPORTED THE PATIENT DIED (B)(6) 2010 FROM COMPLICATIONS OF HEART FAILURE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT, WITH A COMPLEX MEDICAL HISTORY, WAS ADMITTED TO THE HOSPITAL WITH RESPIRATORY FAILURE. THE PATIENT WAS FOUND TO BE SEPTIC, WITH FEVER. HE WAS TRANSFERRED TO ICU AND WAS ON VENTILATOR SUPPORT. THE SOURCE OF THE INFECTION COULD NOT BE IDENTIFIED. THE PATIENT WAS POSITIVE FOR (B) (6). HE ALSO HAD 'BOUTS' OF SINUS TACHYCARDIA AND ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. ADDITIONALLY, HE HAD MULTIPLE SHORT BURSTS OF VENTRICULAR TACHYCARDIA BUT WAS ASYMPTOMATIC AND WAS GIVEN RATE CONTROL MEDICATIONS. PHYSICIAN AND OCCUPATIONAL THERAPY WAS PROVIDED. AFTER 18 DAYS, THE PATIENT WAS TAKEN OFF THE VENTILATOR, AND ONE WEEK LATER, HE WAS DISCHARGED TO A SKILLED NURSING FACILITY IN STABLE CONDITION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT, WITH COMPLEX MEDICAL HISTORY, ADMITTED TO HOSPITAL WITH RESPIRATORY FAILURE. PATIENT WAS FOUND TO BE SEPTIC, WITH FEVER, TRANSFERRED TO ICU ON VENTILATOR SUPPORT. SOURCE OF INFECTION COULD NOT BE IDENTIFIED. PATIENT WAS (B)(6). HAD 'BOUTS' OF SINUS TACHYCARDIA AND ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. HAD MULTIPLE SHORT BURSTS OF VENTRICULAR TACHYCARDIA BUT WAS ASYMPTOMATIC AND GIVEN RATE CONTROL MEDICATIONS. AFTER 18 DAYS, PATIENT TAKEN OFF VENTILATOR, AND ONE WEEK LATER ((B)(6) 2010) DISCHARGED TO SKILLED NURSING FACILITY IN STABLE CONDITION. LATER REPORTED PATIENT DIED (B)(6) 2010 FROM COMPLICATIONS OF HEART FAILURE. HAD BEEN ON HOSPICE, NOT PACEMAKER DEPENDENT, ICD DETECTIONS TURNED OFF 2 MONTHS PRIOR TO DEATH FROM END STAGE CONGESTIVE HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| O