FDA Adverse Event Malfunction Summary report: N

GUIDANT

MDR report key: 3123636 · Received May 9, 2013

Report

Report Number
3123636
Event Type
Malfunction
Date Received
May 9, 2013
Date of Event
March 7, 2013
Report Date
May 9, 2013
Manufacturer
BOSTON SCIENTIFIC
Product Code
LWS
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

NOTES FROM THE CARDIAC CONSULTATION: "RECENT ANALYSIS OF THE ICD, HOWEVER, SHOWED INCREASING IMPEDANCE IN THE RIGHT ATRIAL PACING ELECTRODE AND AN INCREASING PACING THRESHOLD ON THIS LEAD. THE DEVICE WAS ACCORDINGLY REPROGRAMMED. THIS GENERATOR HAD BEEN IMPLANTED IN 2012; FIVE YEARS AFTER ORIGINAL IMPLANT AND THE GENERATOR MAINTAINED ITS INTEGRITY. THE PATIENT IS ADMITTED FOR ATRIAL LEAD MANAGEMENT WITH EXTRACTION AND REINSERTION INDICATED."NOTES FROM THE OPERATIVE REPORT: "WE ATTEMPTED TO PASS THE STYLET DOWN THE ATRIAL PACING ELECTRODE TO WITHDRAW THE ACTIVE FIXATION DEVICE, BUT MET AN OBSTRUCTION AT ABOUT THE LEVEL OF THE CLAVICLE. WE WITHDREW THE ACTIVE FIXATION DEVICE AS BEST WE COULD REMOVE THIS STYLET AND APPLIED GENTLE TRACTION TO THE LEAD, WHICH MOVED IT SOMEWHAT AND SUGGESTED THAT IT COULD BE MORE READILY REMOVED USING A LOCKING STYLET FROM THE LASER KIT.THE LEAD WAS AMPUTATED AND A NUMBER 2 LASER LOCKING STYLET WAS PASSED DOWN ITS LENGTH. USING CONSTANT GENTLE TRACTION AND SOME ROTATIONAL TORSION, THE LEAD WAS REMOVED IN ITS ENTIRETY WITHOUT RESORTING TO THE USE OF THE EXCIMER LASER ENERGY. HEMOSTASIS WAS ADEQUATE." THE PATIENT TOLERATED THE PROCEDURE WELL.PLEASE NOTE THE IMPLANT DID NOT OCCUR AT OUR FACILITY AND WE HAVE NO SPECIFICS ON THE INSERTION DATE, OTHER THAN IT WAS 2007.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ATRIAL PACER LEAD EXTRACTION.ATRIAL PACER LEAD INSERTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
205028 GUIDANT IMPLANTABLE LWS BOSTON SCIENTIFIC 4086 *

Patients

Seq Age Sex Outcome Treatment
1 73 YR