FDA Adverse Event Injury Summary report: N

ATTAIN OTW

MDR report key: 2810666 · Received October 31, 2012

Report

Report Number: 2649622-2012-16289
Event Type: Injury
Date Received: October 31, 2012
Date of Event: June 1, 2012
Report Date: September 19, 2012
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P010015/S003
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: "RESCUE OF AN EPICARDIAL LEFT VENTRICULAR PACING LEAD WITHOUT EXPLANTATION IN A PATIENT WITH CRT-D POCKET INFECTION: MISSION POSSIBLE." HERZSCHRITTMACHERTHER. ELEKTROPHYSIOL. JUNE 1 2012;23(2):128-130.

Description of Event or Problem · 1

A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD. INFORMATION OBTAINED THROUGH FOLLOW UP WITH THE AUTHOR/PHYSICIAN INDICATED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED INCREASED THRESHOLD MEASUREMENTS AS THE POCKET INFECTION WORSENED. THE LEAD WAS REMOVED. THE INFECTION WAS TREATED. THE LEFT VENTRICULAR (LV) LEAD HAD SHOWN AN EXIT-BLOCK DIRECTLY AFTER IMPLANT AND WAS EXPLANTED AND REPLACED AS WELL. FOLLOW UP VISIT INDICATED THAT ALL REPLACEMENT LEAD MEASUREMENTS WERE "STABLE." NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ATTAIN OTW	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC PUERTO RICO, INC.	4193

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Hospitalization\| R	CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB