MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number 4543

Device Problems Pocket Stimulation (1463); High Capture Threshold (3266)

Patient Problem Syncope (1610)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

Should additional information be received, another report will be submitted.

Event Description

It was reported that the patient with this lead sought medical assistance due to syncope.The field representative visited the patient and physician the following day for a system performance evaluation.While in hospital significant pauses on the telemetry, were observed.When the device was interrogated, there were moments of non conducted p-waves on the electrogram; however the device was marking the event as a as-vs, thus no pacing pulses were delivered.So was not pacing.Additionally, the patient was also presenting with twitch on the left ventricular lead.As an effort to reduce the oversensing risk, the physician elected to reprogram the devices rv and lv, sensitivity; no more pacing pauses were then observed.The patients history was then reviewed, at which time it was noted historically high thresholds on both the rv and lv, from the original implant in 2008 however, both have been chronically stable.The twitch had been documented in the implant report, as well as information stating it had been a difficult case.When x-rays were reviewed, it was noticed a suboptimal rv lead position which appeared to be near the tricuspid valve with the coil largely in the atria.X-rays from implant were also reviewed; position appeared stable.Further review of the rv lead, shows a possible degradation.Due to the emotional state of the patient, as well as the sensitivity to even small pauses, the physician elected to not try and recreate the pauses or change the sensitivity.Furthermore, the patient historically had a lbb however, is now pacer dependent.It was felt that the patient was not previously symptomatic due to the recent heart block anomaly.Resolution has been communicated as a possible right system implant and a new lv lead.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado PR 00646 3311
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8534190
• MDR Text Key: 142598925
• Report Number: 2124215-2019-07148
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2010
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening