TELIGEN

MDR report key: 2911834 · Received January 11, 2013

Report

Report Number: 2124215-2012-16230
Event Type: Injury
Date Received: January 11, 2013
Date of Event: December 5, 2012
Report Date: December 10, 2012
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

Additional Manufacturer Narrative · 1

AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION WAS RECEIVED: A REVISION PROCEDURE WAS PERFORMED. AFTER THE POCKET WAS REOPENED, VISUAL INSPECTION REVEALED THE CONNECTIONS WERE REVERSED IN THE DEVICE HEADER. THE CONNECTIONS WERE CORRECTLY SECURED INTO THE DEVICE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST IMPLANT PROCEDURE, A REVIEW OF THE ELECTROGRAM REVEALED DIFFERENT GAIN SETTINGS AND LOW AMPLITUDE IN ADDITION TO HIGH P WAVES. IT WAS SUSPECTED THIS WAS THE RESULT OF THE RIGHT VENTRICULAR HIGH VOLTAGE LEAD CONNECTIONS REVERSED IN THIS DEVICE HEADER. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED. TROUBLESHOOTING RECOMMENDATIONS WERE PROVIDED, HOWEVER REVERSED CONNECTION OF DF-/+ WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
17943	TELIGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	F102

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| L\| R