FDA Adverse Event Injury Summary report: N

THINLINE II STEROX

MDR report key: 2060005 · Received April 15, 2011

Report

Report Number: 2124215-2011-05727
Event Type: Injury
Date Received: April 15, 2011
Date of Event: March 30, 2011
Report Date: April 15, 2011
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVISION WAS PERFORMED AND THIS LEAD WAS CAPPED AND REPLACED WITH A COMPETITOR'S PRODUCT. THE LEAD WILL NOT BE RETURNED FOR LABORATORY ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Additional Manufacturer Narrative · 1

A REVISION HAS BEEN SCHEDULED FOR A LATER DATE. NO ADDITIONAL INFORMATION IS AVAILABLE AND THIS LEAD REMAINS IMPLANTED AS THIS TIME. ONCE THE REVISION HAS BEEN PERFORMED, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, IT WAS DISCOVERED THAT THIS RIGHT VENTRICULAR (RV) LEAD IN THE UNIPOLAR CONFIGURATION DUE TO A LEAD SAFETY SWITCH. THE PACING IMPEDANCE MEASUREMENTS WERE CONFIRMED TO BE ABOVE 2,500 OHMS. IN ADDITION, THERE WAS NO SENSING OR PACING OUTPUTS. A REVIEW OF THE DEVICE MEMORY FOUND THAT THE PACING IMPEDANCE MEASUREMENTS WERE OUT OF RANGE (B)(6) 2011 AND NO R-WAVE WAS AVAILABLE. AN X-RAY WAS PERFORMED AND REVEALED THAT THIS RV LEAD HAD FRACTURED 3 TO 4 CM FROM THE TERMINAL PIN. DURING THE FOLLOW UP, THIS PATIENT WAS EXPERIENCING AN ATRIAL FIBRILLATION THAT IS CONDUCTING INTO THE VENTRICLE BUT WAS NOT EXHIBITING ANY SYMPTOMS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	THINLINE II STEROX	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	4371

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other