FDA Adverse Event Malfunction Summary report: N

CAPSUREFIX NOVUS

MDR report key: 1926278 · Received December 14, 2010

Report

Report Number: 2649622-2010-14258
Event Type: Malfunction
Date Received: December 14, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P930039/S009
Removal / Correction Number: ASKU
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A LEAD IMPEDANCE WARNING WAS SHOWN ON CARELINK AND IT WAS NOTED THAT THERE WERE MORE THAN 30,000 LOW IMPEDANCE PACES RECORDED. THE SENSING AND THRESHOLD VALUES HAVE NOT CHANGED AND NO NOISE WAS NOTED ON THE LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT A LEAD IMPEDANCE WARNING WAS SHOWN ON CARELINK AND IT WAS NOTED THAT THERE WERE MORE THAN 30,000 LOW IMPEDANCE PACES RECORDED. THE SENSING AND THRESHOLD VALUES HAVE NOT CHANGED AND NO NOISE WAS NOTED ON THE LEAD. IT WAS FURTHER REPORTED THAT THE PATIENT INDICATED THAT THEY HAVE NO "GET UP AND GO" AND THAT A VENTRICULAR LEAD WARNING OCCURRED ON (B)(6) 2010. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CAPSUREFIX NOVUS	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC PUERTO RICO, INC.	5076	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Other	5076 IMPLANTABLE PACING LEAD\| (B)(4) IMPLANTABLE PULSE GENERATOR\| 5076 IMPLANTABLE PACING LEAD\| (B)(4) IMPLANTABLE PULSE GENERATOR