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

Model Number 4542

Device Problems Failure to Capture (1081); High impedance (1291); Ambient Noise Problem (2877); Capturing Problem (2891); Device Sensing Problem (2917); Material Integrity Problem (2978); High Capture Threshold (3266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that abrupt changes in the left ventricular (lv) lead pace impedance measurements as well as loss of capture was noted via remove monitoring.The patient was checked at the clinic and no asystole was noted, but noise was seen with arm movements and the pace impedance measurements were out of range as well as high pacing thresholds were noted using the ring electrode.The cardiac resynchronization therapy defibrillator (crt-d) was reprogrammed ring to right ventricle for sensing and pacing and no noise was seen, good pacing thresholds, and normal pace impedance measurements.A follow up was scheduled.No adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Additional information noted that continued out of range pace impedance measurements were seen on this left ventricular (lv) lead and loss of capture was seen in all configurations, thus an lv lead fracture was suspected.The crt-d was reprogrammed to lv lead off and right ventricular (rv) lead only pacing.The patient will be booked for a new lv lead.No adverse patient effects were reported.Additional information received noted that a revision took place and this lv lead was left insitu while the device was explanted.The lead fracture was confirmed electrically but not visually or on x-ray.

• 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: 7619962
• MDR Text Key: 111691912
• Report Number: 2124215-2018-10309
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/16/2013
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 147448
• Other Device ID Number: EASYTRAK 2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2011
• 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
• Treatment: 0295; 4136; 4542; N108
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR