FDA Adverse Event Malfunction Summary report: N

PROTECTA XT CRT-D

MDR report key: 2952817 · Received February 9, 2013

Report

Report Number: 9614453-2013-00141
Event Type: Malfunction
Date Received: February 9, 2013
Date of Event: November 28, 2012
Report Date: November 28, 2012
Manufacturer: IPG MFG SWITZERLAND
Product Code: NIK
PMA / PMN Number: P010031
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PO
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS IN THE SAME FAMILY TO A DEVICE MARKETED IN THE U.S. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT A TEST LEAD WAS INSERTED INTO ALL PORTS AND ALL SETSCREWS WERE TIGHTENED TO ONE CLICK USING MEDTRONIC TORQUE WRENCH. ALL SETSCREWS HELD AND SECURED THEIR LEADS. NO ANOMALIES WERE FOUND. (B)(4).

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: PERFORMANCE DATA WAS ALSO COLLECTED FROM THE DEVICE, ANALYZED, AND NO ANOMALIES WERE FOUND.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN THE PHYSICIAN WENT TO UNSCREW THE SETSCREW TO REINSERT THE LEAD IN THE HEADER, IT WAS NOT POSSIBLE AS THE SCREW SEEMED TO BE FIXED DAMAGING THE TORQUE. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
55800	PROTECTA XT CRT-D	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO	NIK	IPG MFG SWITZERLAND	D354TRG

Patients

Seq	Age	Sex	Outcome	Treatment
1