FDA Adverse Event Death Summary report: N

CAPSUREFIX NOVUS

MDR report key: 3833539 · Received May 27, 2014

Report

Report Number: 2649622-2014-04864
Event Type: Death
Date Received: May 27, 2014
Date of Event: March 4, 2014
Report Date: June 10, 2014
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

THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. NO CONTACTS/EVENTS REGARDING THE SYSTEM HAVE EVER BEEN RECEIVED/REPORTED. THE SERIAL NUMBERS OF THE DEVICES ARE NOT REGISTERED IN THE MANUFACTURE DATABASE. THEREFORE PATIENT INFORMATION IS UNKNOWN. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. PRODUCTS: (B)(4) ICD IMPLANTED: UNKNOWN; 694765 LEAD IMPLANTED: UNKNOWN. (B)(4).

Additional Manufacturer Narrative · 1

PRODUCT EVENT: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED FROM AN UNKNOWN MORTUARY WITH NO INFORMATION. THE ICD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
310403	CAPSUREFIX NOVUS	ELECTRODE, PACEMAKER, PERMANENT	DTB	MPRI	407652

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death