CAPSUREFIX NOVUS

Report

Report Number: 2649622-2010-08983
Event Type: Death
Date Received: September 10, 2010
Date of Event: July 23, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S009
Removal / Correction Number: ASKU
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, 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. INFORMATION SUBSEQUENTLY RECEIVED ON 9/7/2010 REVEALED THE PATIENT HAD DIED. OF NOTE, THE REPORTABLE INJURY IS NORMALLY SUBMITTED VIA A (B)(4) MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON 10/10/2010. HOWEVER, AS THERE IS NOW INFORMATION THAT REASONABLY SUGGESTS THAT THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS NOW REQUIRES SUBMISSION AS A 30-DAY REPORT.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INFORMATION SUBSEQUENTLY RECEIVED ON 9/7/2010 REVEALED THE PATIENT HAD DIED. OF NOTE, THE REPORTABLE INJURY IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON 10/10/2010. HOWEVER, AS THERE IS NOW INFORMATION THAT REASONABLY SUGGESTS THAT THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS NOW REQUIRES SUBMISSION AS A 30-DAY REPORT. ANALYSIS OF THE DEVICE 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. INFORMATION SUBSEQUENTLY RECEIVED ON 9/7/2010 REVEALED THE PATIENT HAD DIED. OF NOTE, THE REPORTABLE INJURY IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON 10/10/2010. HOWEVER, AS THERE IS NOW INFORMATION THAT REASONABLY SUGGESTS THAT THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS NOW REQUIRES SUBMISSION AS A 30-DAY REPORT. (B)(4) - PRELIMINARY ANALYSIS REVEALED THE DEVICE WAS IN A NO OUTPUT AND NO TELEMETRY STATE. FURTHER ANALYSIS REVEALED THE NO OUTPUT AND NO TELEMETRY CONDITION WAS THE RESULT OF BATTERY DEPLETION.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INFORMATION SUBSEQUENTLY RECEIVED ON 9/7/2010 REVEALED THE PATIENT HAD DIED. OF NOTE, THE REPORTABLE INJURY IS NORMALLY SUBMITTED VIA A (B)(4) MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON 10/10/2010. HOWEVER, AS THERE IS NOW INFORMATION THAT REASONABLY SUGGESTS THAT THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS NOW REQUIRES SUBMISSION AS A 30-DAY REPORT.(B)(4) - BATTERY DEPLETION NORMAL.

Description of Event or Problem · 1

IT WAS REPORTED THE LEAD WAS NOT CAPTURING UNIPOLAR, HAD DECREASED IMPEDANCE UNIPOLAR, BOTH INCREASED AND DECEASED IMPEDANCE BIPOLAR, AND HIGH THRESHOLD. LEAD FRACTURE SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED 17 DAYS LATER. 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 THE LEAD WAS MALFUNCTIONING - NOT CAPTURING UNIPOLAR, HAD DECREASED IMPEDANCE UNIPOLAR, BOTH INCREASED AND DECEASED IMPEDANCE BIPOLAR, AND HIGH THRESHOLD. LEAD FRACTURE SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED 17 DAYS LATER. 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. FOLLOW UP WITH CLINIC REVEALED PATIENT HAD BEEN NONCOMPLIANT WITH DEVICE CHECKS AND CARDIOLOGY VISITS. VISIT ON (B)(6) 2010 NOTED ERI HAD TRIGGERED IN (B)(6) 2009, IMPEDANCES HIGH AT TIMES, LOSS OF CAPTURE, AND VENTRICULAR LEAD FRACTURE. DEVICE REPLACED AT THE TIME OF LEAD REPLACEMENT. PATIENT SEEN (B)(6) 2010 AND WAS DOING FINE. NURSES OBSERVED A PAUSE ON THE PATIENT MONITOR ON THE DAY OF DEATH, BUT AGREED IT OCCURRED WHILE MANUFACTURER'S REPRESENTATIVE WAS CHECKING THE DEVICE. PHYSICIAN WAS NOT CONCERNED ABOUT ANY DEVICE ISSUE.

Description of Event or Problem · 1

IT WAS REPORTED THE LEAD WAS MALFUNCTIONING - NOT CAPTURING UNIPOLAR, HAD DECREASED IMPEDANCE UNIPOLAR, BOTH INCREASED AND DECEASED IMPEDANCE BIPOLAR, AND HIGH THRESHOLD. LEAD FRACTURE SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED 17 DAYS LATER. 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. FOLLOW UP WITH CLINIC REVEALED PATIENT HAD BEEN NONCOMPLIANT WITH DEVICE CHECKS AND CARDIOLOGY VISITS. VISIT ON (B)(6) 2010 NOTED ERI HAD TRIGGERED IN (B)(6) 2009, IMPEDANCES HIGH AT TIMES, LOSS OF CAPTURE, AND VENTRICULAR LEAD FRACTURE. DEVICE REPLACED AT THE TIME OF LEAD REPLACEMENT. PATIENT SEEN (B)(6) 2010 AND WAS DOING FINE. NURSES OBSERVED A PAUSE ON THE PATIENT MONITOR ON THE DAY OF DEATH, BUT AGREED IT OCCURRED WHILE MANUFACTURER'S REPRESENTATIVE WAS CHECKING THE DEVICE. PHYSICIAN WAS NOT CONCERNED ABOUT ANY DEVICE ISSUE.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	88 YR		Death	(B)(4) IMPLANTABLE PULSE GENERATOR\| (B)(4) IMPLANTABLE PULSE GENERATOR\| (B)(4) IMPLANTABLE PULSE GENERATOR\| (B)(4) IMPLANTABLE PULSE GENERATOR