FDA Adverse Event Malfunction Summary report: N

INGEVITY

MDR report key: 4140033 · Received October 3, 2014

Report

Report Number: 2124215-2014-16525
Event Type: Malfunction
Date Received: October 3, 2014
Date of Event: August 20, 2014
Report Date: September 5, 2014
Manufacturer: CPI - DEL CARIBE
Product Code: NVN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE LEAD AND DEVICE REMAIN 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 RECEIVED INFORMATION THAT AT THE PACEMAKER FOLLOW UP APPROXIMATELY SIX WEEKS POST-IMPLANT, THE LEAD SAFETY SWITCH (LSS) HAD BEEN OBSERVED AND THE DEVICE WAS IN THE UNIPOLAR PACING CONFIGURATION. DEVICE INTERROGATION SHOWED PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2,000 OHMS IN THE BIPOLAR CONFIGURATION. TWO DAYS LATER, LOSS OF CAPTURE WAS OBSERVED IN THE BIPOLAR CONFIGURATION. AN X-RAY WAS PERFORMED, WHICH REVEALED THE TERMINAL PIN WAS UNDER-INSERTED INTO THE DEVICE HEADER. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT REVIEWED THE X-RAY AND AGREED WITH THAT ASSESSMENT. IT WAS ALSO OBSERVED THAT THE LEAD WAS AT A SHARP ANGLE AT THE EXIT OF THE DEVICE HEADER. THEREFORE, ADDITIONAL TROUBLESHOOTING WAS SUGGESTED TO ENSURE THE LEAD WAS NOT DAMAGED. HOWEVER, THE FIELD REPRESENTATIVE CONFIRMED THAT THE PATIENT WAS NOT PACEMAKER DEPENDENT AND THE PHYSICIAN WAS NOT PLANNING AN INVASIVE PROCEDURE TO CORRECT THE CONNECTIONS AS THE LEAD MEASUREMENTS IN THE UNIPOLAR CONFIGURATION WERE ACCEPTABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
620723	INGEVITY	IMPLANTABLE LEAD	NVN	CPI - DEL CARIBE	7742

Patients

Seq	Age	Sex	Outcome	Treatment
1				J275\| 7742