CAPSURE SP

Report

Report Number: 2649622-2010-09581
Event Type: Injury
Date Received: October 18, 2010
Date of Event: August 24, 2010
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P830061/S12
Removal / Correction Number: ASKU
Adverse Event: Yes
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.

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 LEAD IMPEDANCES HAVE DROPPED TO A LOW VALUE ON BOTH THE ATRIAL AND VENTRICULAR LEADS. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT LEAD IMPEDANCES HAVE DROPPED TO A LOW VALUE ON BOTH THE ATRIAL AND VENTRICULAR LEADS. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD SHOWN A STEADY DECLINE IN LEAD IMPEDANCE, SENSING THRESHOLD DECREASED, AND PACING THRESHOLD INCREASED. THE LEAD WAS PARTIALLY REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CAPSURE SP	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC PUERTO RICO, INC.	4024	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR		Hospitalization\| O\| R	(B)(4) IMPLANTABLE PULSE GENERATOR\| 7960 IMPLANTABLE PULSE GENERATOR