FDA Adverse Event Injury Summary report: N

TELIGEN

MDR report key: 2052899 · Received April 13, 2011

Report

Report Number: 2124215-2011-04143
Event Type: Injury
Date Received: April 13, 2011
Date of Event: February 28, 2011
Report Date: February 28, 2011
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

ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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

BOSTON SCIENTIFIC (BSC) RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE WAS PRESENTED IN THE CLINIC. UPON REVIEW, FIVE EPISODES OF NOISE ON THE NON-BSC RIGHT VENTRICULAR (RV) LEAD WERE OBSERVED, RESULTING IN PACING INHIBITION. THE PATIENT PERFORMED ISOMETRICS, WHICH DID NOT RECREATE THE NOISE. TECHNICAL SERVICES DISCUSSED RECOMMENDATIONS FOR FURTHER EVALUATION. A DEVICE ENGINEERING ANALYSIS WAS PERFORMED. ANALYSIS RESULTS CONFIRMED EPISODES WITH EVIDENCE OF A POSSIBLE SENSING ISSUE. THE DEVICE HAD RECORDED NO SIGNIFICANT FAULTS AND WAS CONFIRMED TO BE FUNCTIONING NORMALLY. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND A NEW RV LEAD WAS IMPLANTED. AT THE DEVICE CHECK THE FOLLOWING DAY, THE P-WAVES WERE VERY PRONOUNCED AND THE RA-WAVES ARE FLAT AND WIDE. AN ALLEGATION OF LEADS REVERSED IN THE HEADER WAS MADE. NO FURTHER OBSERVATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TELIGEN	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	E110

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR			E110\| 6947\| 7273\| 5076