MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO MRI EL DR; IMPLANTABLE DEVICE

Model Number L131

Device Problems Difficult to Insert (1316); Over-Sensing (1438)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

Event Type  Injury  

Event Description

It was reported that post implant procedure there was intermittent noise on the right ventricular (rv) channel.Troubleshooting was performed and when the pocket was manipulated there were observations of noise.The physician re-opened the pocket and verified all the connections were fully inserted.The device was re-programmed to bipolar however, could still see noise when the can was manipulated.Technical services believes the noise was related to air bubbles.Additionally, it was noted that the lead had been inserted twice into the device and the physician had difficulty inserting the first time and felt it was not fully inserted however, measurements were all within normal range.The physician did re-position the lead and the lead was successfully connected.The patient did have a post-operative wound check and a successful interrogation was performed and there is no evidence of noise and all measurements are within range.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation noted evidence indicating difficulty may have been encountered fully inserting a lead into the header of this device.Additionally, the noise on the channel was consistent with temporary body fluid infiltration through the seal plug, coupled with air escaping the seal plug.Please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that post implant procedure there was intermittent noise on the right ventricular (rv) channel.Troubleshooting was performed and when the pocket was manipulated there were observations of noise.The physician re-opened the pocket and verified all the connections were fully inserted.The device was re-programmed to bipolar however, could still see noise when the can was manipulated.Technical services believes the noise was related to air bubbles.Additionally, it was noted that the lead had been inserted twice into the device and the physician had difficulty inserting the first time and felt it was not fully inserted however, measurements were all within normal range.The physician did re-position the lead and the lead was successfully connected.The patient did have a post-operative wound check and a successful interrogation was performed and there is no evidence of noise and all measurements are within range.No additional adverse patient effects were reported.

• Brand Name: ESSENTIO MRI EL DR
• Type of Device: IMPLANTABLE DEVICE
• 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: 14503215
• MDR Text Key: 292699316
• Report Number: 2124215-2022-14638
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559006
• UDI-Public: 00802526559006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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: Lay User/Patient
• Device Expiration Date: 03/06/2024
• Device Model Number: L131
• Device Catalogue Number: L131
• Device Lot Number: 982418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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
• Patient Age: 85 YR
• Patient Sex: Male