MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK ENDURANCE RX; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0144

Device Problems Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); Ambient Noise Problem (2877); Device Sensing Problem (2917)

Patient Problem Muscle Stimulation (1412)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) lead had two stored episodes of noise with oversensing that led to pacing inhibition.The noise was unable to be reproduced with isometrics or pocket manipulation.Boston scientific technical services (ts) reviewed strips and noted the possibility that the patient was having diaphragmatic oversensing.Ts discussed additional testing.The system remains in service and the sensing was changed from nominal to 0.7 mv.No adverse patient effects were reported.

Manufacturer Narrative

Additional information was received that there was another episode of myopotential noise which was oversensed.The episode was three fast beats with a one second duration and then the patient's intrinsic beat came through.No further episodes have been reported.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Manufacturer Narrative

It was reported that this system has continued to exhibit noise, oversensing and pacing inhibition.There were no pacing pauses greater than two seconds and the patient was asymptomatic.The noise could be reproduced during isometrics.Due to the patient's age, the physician does not want to perform any invasive procedures.Therefore, some reprogramming was performed.A boston scientific technical services consultant reviewed the possible causes of the reported clinical observations.The patient will continue to be followed.No adverse patient effects were reported.

Event Description

This supplemental report is being filed due to the receipt of additional pertinent information.

• Brand Name: ENDOTAK ENDURANCE RX
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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 vasekar ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 5823848
• MDR Text Key: 50515677
• Report Number: 2124215-2016-09577
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/26/2001
• Device Model Number: 0144
• Device Catalogue Number: 0144
• Device Lot Number: 304097
• Other Device ID Number: ENDOTAK ENDURANCE RX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: 08/28/2017; 05/01/2019
• Supplement Dates FDA Received: 11/07/2017; 08/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 92 YR