FDA Adverse Event Death Summary report: N

CAPSUREFIX NOVUS

MDR report key: 3141330 · Received June 3, 2013

Report

Report Number: 2649622-2013-05473
Event Type: Death
Date Received: June 3, 2013
Date of Event: January 10, 2011
Report Date: June 19, 2013
Manufacturer: MPRI
Product Code: DTB
PMA / PMN Number: P930039
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: (B)(4). THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD WAS PERFORMED.

Additional Manufacturer Narrative · 1

A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED AND THE PATIENT WAS IDENTIFIED AS BEING DECEASED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. HOWEVER, IF ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED: (B)(6) 2010; (B)(4)IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2010.

Description of Event or Problem · 1

AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH NO ADDITIONAL INFORMATION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY TWO MONTHS POST IPG SYSTEM IMPLANT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
245053	CAPSUREFIX NOVUS	ELECTRODE, PACEMAKER, PERMANENT	DTB	MPRI	407652

Patients

Seq	Age	Sex	Outcome	Treatment
1	00087 YR		Death