FDA Adverse Event Death Summary report: N

ATTAIN OTW

MDR report key: 2944698 · Received February 5, 2013

Report

Report Number: 2649622-2013-00072
Event Type: Death
Date Received: February 5, 2013
Date of Event: May 31, 2009
Report Date: February 11, 2013
Manufacturer: MPRI
Product Code: LWP
PMA / PMN Number: P010015
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

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. THE PRODUCTS ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. A CAUSE OF DEATH WILL NOT BE RECEIVED. (B)(4). CONCOMITANT MEDICAL PRODUCTS: (B)(4), IMPLANTABLE PACING LEAD, (B)(6) 2008; (B)(4), IMPLANTABLE PULSE GENERATOR, (B)(6) 2008.

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY # (B)(4) - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. A VISUAL ANALYSIS WAS PERFORMED ONLY.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS POST THE RIGHT ATRIAL LEAD IMPLANT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
49070	ATTAIN OTW	PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE	LWP	MPRI	419478

Patients

Seq	Age	Sex	Outcome	Treatment
1	00078 YR		Death	5092-58 IMPLANTABLE PACING LEAD