FDA Adverse Event Summary report: N

TENDRIL DX

MDR report key: 2933135 · Received January 10, 2013

Report

Report Number
2933135
Date Received
January 10, 2013
Date of Event
January 4, 2013
Report Date
January 10, 2013
Manufacturer
ST. JUDE MEDICAL
Product Code
DTB
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

NOTES FROM THE DISCHARGE SUMMARY: THIS PATIENT HAD A "PACER IMPLANTED FOR SICK SINUS SYNDROME, AND HAD A GENERATOR REPLACEMENT A YEAR AGO. SHE DEMONSTRATED HIGH IMPEDANCE ON HER ATRIAL ELECTRODE WITH CONSIDERABLE NOISE WHEN HER DEVICE WAS INTERROGATED IN THE CARDIOLOGIST'S OFFICE. SHE WAS SYMPTOMATIC WITH FATIGUE AND SOME DYSPNEA AND LIGHTHEADEDNESS. SHE WAS PACING MINIMALLY, HOWEVER. SHE IS ADMITTED FOR LEAD REPLACEMENT." NOTES FROM THE OPERATIVE REPORT: ..."THE INCISION WAS CARRIED DOWN TO ENTER THE PACER POCKET. THE LEADS WERE MOBILIZED WITH RESECTION OF SOME OF THE FIBROUS CAPSULE OF THE POCKET, BUT THERE WERE VERY FEW ADHESIONS WITHIN THIS POCKET. THE LEADS WERE FREED DOWN TO THEIR INSERTION SITE. THE LEADS WERE EXAMINED UNDER FLUOROSCOPY AND THERE WAS NO OBVIOUS FRACTURE NOTED. THE ATRIAL LEAD WAS DISCONNECTED FROM THE HEADER DEVICE WAS FIRMLY SEATED.... A STYLET WAS PASSED DOWN THE CHRONIC FRACTURED RIGHT ATRIAL PACER ELECTRODE. THE ACTIVE FIXATION DEVICE WAS WITHDRAWN. CONSTANT GENTLE TRACTION ON THE LEAD FAILED TO DISLODGE IT WERE REMOVED AND ACCORDINGLY THE LEAD WAS AMPUTATED. A LOCKING STYLET WAS PASSED DOWN THE LEAD. A 14-FRENCH EXCIMER LASER WAS MOBILIZED. THE LEAD WAS REMOVED IN ITS ENTIRETY WITHOUT DIFFICULTY."... THE PATIENT WAS "TAKEN TO POST-ANESTHESIA CARE UNIT (PACU) IN SATISFACTORY CONDITION HAVING TOLERATED THE PROCEDURE WELL."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
16071 TENDRIL DX IMPLANTABLE DTB ST. JUDE MEDICAL 1388T/52 *

Patients

Seq Age Sex Outcome Treatment
1 82 YR