MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L101

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that the patient implanted with this pacemaker felt unwell one day after the device replacement procedure and returned to the hospital.Loss of capture on the right ventricular (rv) channel was observed on the hospital monitoring equipment, with no syncope reported.During testing, pacing threshold measurements remains normal and stable.The output on the rv lead was increased to 7.5v and the mode was changed to vvi.After this reprogramming no other signs of loss of capture where observed.The patient was hospitalized and monitored.Four days later the field representative attended to check the device.There were two signal artifact monitor (sam) episodes stored showing high, out-of-range pacing impedance measurements on the right atrial (ra) and rv leads, with a flat electrogram and some non-cardiac signals.These were stored on the date the patient returned to the hospital.No noise was produced during troubleshooting.Device data was reviewed by engineering and technical services.It was noted an atr episode was stored before the sam episodes and showed appropriate sensing and pacing.The data showed there were no faults and device operation appeared normal.The field representative confirmed that at the time of the sam episodes, the patient was laying in the bed, already hospitalized and monitored.X-rays were reviewed, but were not sufficiently clear to verify whether the lead terminal pins were fully inserted into the device.Header.No adverse patient effects were reported.Available information indicates the patient remains hospitalized pending a resolution.The field representative later reported that the patient underwent a system explant and replacement procedure at another hospital and has since been discharged in good condition.

• Brand Name: ESSENTIO DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9638274
• MDR Text Key: 176640065
• Report Number: 2124215-2019-28759
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/22/2021
• Device Model Number: L101
• Device Catalogue Number: L101
• Device Lot Number: 782695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2019
• 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 Outcome(s): Hospitalization; Required Intervention