FDA Adverse Event Malfunction Summary report: N

PACESETTER

MDR report key: 1222493 · Received November 3, 2008

Report

Report Number
1222493
Event Type
Malfunction
Date Received
November 3, 2008
Date of Event
July 25, 2008
Report Date
November 3, 2008
Manufacturer
ST. JUDE MEDICAL CARDIAC RHYTHM
Product Code
DTB
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THE PATIENT HAD A PACEMAKER INSERTED AND ST. JUDE ATRIAL AND VENTRICULAR LEADS. THREE WEEKS LATER, THE PATIENT RETURNED TO THE OR FOR REMOVAL AND REPLACEMENT OF A NEW ATRIAL FIXATION LEAD. THE NEW ATRIAL LEAD WAS A PACESETTER MODEL 1388. AFTER APPROXIMATELY SIX YEARS, THE PATIENT UNDERWENT REPLACEMENT OF THE ATRIAL AND VENTRICULAR LEAD. THE FOLLOWING NOTES ARE TAKEN DIRECTLY FROM THE OPERATIVE NOTE: PREOPERATIVELY, IT WAS DETERMINED THAT THE ATRIAL LEAD HAD IMPEDANCE OF GREATER THAN 2000, SUGGESTING INSULATION BREAK. THE VENTRICULAR LEAD APPEARED TO BE SATISFACTORY, ALTHOUGH A DECISION WAS MADE TO ANALYZE THIS LEAD INTRAOPERATIVELY, AS WELL. WE EXCISED THE EXISTING IMPLANTING SCAR ON THE LEFT INFRACLAVICULAR CHEST WALL AND CARRIED THE INCISION DOWN TO ENTER THE PACER POCKET. THE PACER WAS DELIVERED INTO THE WOUND. THE LEADS WERE DISSECTED FREE FROM THEIR ADHESIONS TO THE FIBROUS CAPSULE OF THE POCKET. THEN, THE LEADS WERE DISSECTED DOWN TO THEIR INSERTION SITES FREEING THEIR SUTURE LIGATION TO THE CHEST WALL. THE ATRIAL LEAD WAS DISCONNECTED FROM THE HEADER OF THE DEVICE AND ONCE AGAIN THE IMPEDANCE CONFIRMED TO BE EXCEEDINGLY HIGH. WE ATTEMPTED TO PASS A STYLET DOWN THIS LEAD AND WE WERE UNABLE TO DO SO MORE THAN A DISTANCE OF APPROXIMATELY 2 INCHES. CLOSER INSPECTION OF THE LEAD REVEALED TOTAL DISRUPTION AND DENUDING OF THE INSULATION FROM THE LEAD. WE DISCONNECTED THE VENTRICULAR LEAD FROM THE HEADER OF THE OLD DEVICE, WHICH HAD REACHED THE ERI. THIS WAS GUIDANT, MODEL 1298. THE PATIENT HAD A VERY SLOW UNDERLYING RHYTHM AND REQUIRED PACING THROUGH THE CHRONIC RV ELECTRODE. ANALYSIS OF THIS LEAD NOW REVEALED THAT THE PATIENT'S R WAVE SENSING WAS VERY POOR IN THE RANGE OF 2 MILLIVOLTS R WAVES. THROUGH THE DEVICE ITSELF, THEY HAD BEEN 3 TO 3.5, WHICH WE FELT WAS ACCEPTABLE. THESE READINGS BY DIRECT MEASUREMENT ON THE LEAD WERE UNACCEPTABLE AND WE ELECTED TO REMOVE THIS LEAD AS WELL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PACESETTER LEAD, PACEMAKER, ATRIAL DTB ST. JUDE MEDICAL CARDIAC RHYTHM 1388 *
2 PACESETTER LEAD, PACEMAKER, VENTRICULAR DTB ST. JUDE MEDICAL CARDIAC RHYTHM 1488 *

Patients

Seq Age Sex Outcome Treatment
1 73 YR