FDA Adverse Event Malfunction Summary report: N

FINELINE II

MDR report key: 4131736 · Received October 1, 2014

Report

Report Number: 2124215-2014-14500
Event Type: Malfunction
Date Received: October 1, 2014
Date of Event: July 15, 2014
Report Date: July 15, 2014
Manufacturer: CPI - DEL CARIBE
Product Code: DTB
PMA / PMN Number: P960004
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. 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 RECEIVED INFORMATION THAT P-WAVE MEASUREMENTS WERE FLUCTUATING AND THE RIGHT ATRIAL (RA) LEAD IMPEDANCE MEASUREMENT WAS GREATER THAN 2000 OHMS FOR ONE RECORDING. IT WAS SUSPECTED THERE WAS AN INTERMITTENT OPEN CIRCUIT ON THE RA LEAD. REVIEW OF THE STORED ELECTROGRAM (EGM) SHOWED EPISODES WITH NOISE ON BOTH CHANNELS MOST LIKELY RELATED TO NON-CARDIAC SIGNALS AND RELATED TO POTENTIAL MECHANICAL LEAD ISSUE AND EXTERNAL ELECTROMAGNETIC INTERFERENCE (EMI) SOURCES. THERE WAS NO ASYSTOLE AS A RESULT OF THE NOISE AND OVERSENSING AS THE PATIENT HAD AN UNDERLYING RHYTHM. DEVICE MEMORY REVIEW FROM OUR ENGINEERS CONFIRMED THAT THIS DEVICE HAS NO RESETS. A LEAD LEAKAGE IN SESSION FAULT OCCURRED. THIS TYPE OF FAULT OCCURS WHEN THE DEVICE DETECTS ENERGY ON THE LEAD GENERALLY FROM ELECTRO-CAUTERY. THIS TYPE OF FAULT IS NOT ABNORMAL AND DOES OCCUR DURING IMPLANT OR LEAD REVISIONS AND COULD EXPLAIN SOME OF THE NOISE OBSERVED IN THE EPISODES RECORDED ON THAT DAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
612653	FINELINE II	IMPLANTABLE LEAD	DTB	CPI - DEL CARIBE	4480

Patients

Seq	Age	Sex	Outcome	Treatment
1				J279\| 4480\| 4457