FDA Adverse Event Malfunction Summary report: N

CAPSURE

MDR report key: 2844068 · Received November 25, 2012

Report

Report Number: 2182208-2012-04045
Event Type: Malfunction
Date Received: November 25, 2012
Report Date: December 4, 2012
Manufacturer: RICE CREEK MFG
Product Code: DTB
PMA / PMN Number: P950024
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

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. CONCOMITANT PRODUCTS: 4965 IMPLANTABLE PACING LEAD 2006 (B)(6); 6981M IMPLANTABLE ADAPTOR 2008 (B)(6). (B)(4). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS LATER REPORTED THAT THERE WAS NOISE, DROPPED P WAVES AND LATE SENSING OF THE RA LEAD. IT WAS ALSO NOTED THAT THERE WAS POSSIBLE MODE SWITCHING OCCURRING. THE RIGHT VENTRICULAR (RV) LEAD WAS REPORTED AS HAVING HIGH THRESHOLDS. THE RA LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE RV LEAD REMAINS IN USE WITH A POSSIBILITY OF LEAD REVISION TAKING PLACE IN A FEW MONTHS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD DECREASED SENSING OF P WAVES AND WAS OVERSENSING. NO CHANGES HAVE BEEN MADE AT THIS TIME AND THE RA LEAD REMAINS IN USE. THE RA LEAD WILL BE MONITORED AS THE PATIENT GROWS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CAPSURE	ELECTRODE, PACEMAKER, PERMANENT	DTB	RICE CREEK MFG	4965-35

Patients

Seq	Age	Sex	Outcome	Treatment
1				(B)(4) IMPLANTABLE PULSE GENERATOR