ATTAIN STARFIX

Report

Report Number: 2649622-2011-00130
Event Type: Death
Date Received: January 27, 2011
Date of Event: December 24, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P060039
Removal / Correction Number: ASKU
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: ND, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS OF THE DEVICE AND LEADS ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

ANALYSIS OF THE LEADS ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. 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 DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

Additional Manufacturer Narrative · 1

THE LAST INTERROGATION OF THE CRT-D WAS THREE MONTHS PRIOR TO DEATH WHICH ONLY SHOWED THAT THE OPTIVOL FLUID INDEX WAS INCREASING, WHICH WOULD BE CONSISTENT WITH SYMPTOMATIC CONGESTIVE HEART FAILURE. OTHERWISE THE DEVICE MEASUREMENTS WERE WITH IN NORMAL LIMITS. 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 DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS CUT, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, 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), THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER INSULATION WAS BREACHED CUT, OUTER TUBING OVERLAY WAS BREACHED CUT AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL THE INSULATORS WERE BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE.

Description of Event or Problem · 1

A CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) SYSTEM WAS RECEIVED AND RETURNED WITH NO INFORMATION. PER THE MANUFACTURE DATA BASE THE PATIENT HAD DIED APPROXIMATELY NINE MONTHS POST IMPLANT OF THE CRT-D AND LEFT VENTRICULAR LEAD. THROUGH THE FOLLOW-UP PROCESS IT WAS REVEALED THAT THE PATIENT HAD BEEN SEEN IN THE CLINIC ONE MONTH PRIOR TO THE DAY OF DEATH FOR MANAGEMENT OF CONGESTIVE HEART FAILURE. THEY HAD DEVELOPED SHORTNESS OF BREATH, COUGH, AND INCREASED WEIGHT GAIN. THESE SYMPTOMS WERE BEING MANAGED BY DIURETIC THERAPY. THE PATIENT WAS SEEN IN THE CLINIC THE DAY BEFORE DEATH WHERE THE SYMPTOMS HAD IMPROVED AND DIURETIC MANAGEMENT SEEMED UNDER CONTROL. THE PATIENT DIED THE NEXT DAY. CAUSE OF DEATH WAS REQUESTED BUT NOT KNOWN BY THE CARDIOLOGY CLINIC OR PRIMARY CLINIC. NO FUNERAL HOME CONTACT IS AVAILABLE.

Description of Event or Problem · 1

A CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) SYSTEM WAS RECEIVED AND RETURNED WITH NO INFORMATION. PER THE MANUFACTURE DATA BASE THE PATIENT HAD DIED APPROXIMATELY NINE MONTHS POST IMPLANT OF THE CRT-D AND LEFT VENTRICULAR LEAD. THROUGH THE FOLLOW-UP PROCESS IT WAS REVEALED THAT THE PATIENT HAD BEEN SEEN IN THE CLINIC ONE MONTH PRIOR TO THE DAY OF DEATH FOR MANAGEMENT OF CONGESTIVE HEART FAILURE. THEY HAD DEVELOPED SHORTNESS OF BREATH, COUGH, AND INCREASED WEIGHT GAIN. THESE SYMPTOMS WERE BEING MANAGED BY DIURETIC THERAPY. THE PATIENT WAS SEEN IN THE CLINIC THE DAY BEFORE DEATH WHERE THE SYMPTOMS HAD IMPROVED AND DIURETIC MANAGEMENT SEEMED UNDER CONTROL. THE PATIENT DIED THE NEXT DAY. CAUSE OF DEATH WAS REQUESTED BUT NOT KNOWN BY THE CARDIOLOGY CLINIC OR PRIMARY CLINIC. NO FUNERAL HOME CONTACT IS AVAILABLE. THE LAST INTERROGATION OF THE CRT-D WAS THREE MONTHS PRIOR TO DEATH WHICH ONLY SHOWED THAT THE OPTIVOL FLUID INDEX WAS INCREASING, WHICH WOULD BE CONSISTENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ATTAIN STARFIX	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC PUERTO RICO, INC.	4195	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR		Death