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

Model Number L331

Device Problems Over-Sensing (1438); Failure to Select Signal (1582); Device Sensing Problem (2917); Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.Upon further information this investigation will be updated.

Event Description

It was reported that a troubleshooting review or electrocardiograms was sent to boston scientific technical services (ts).Provided electrocardiogram and review by ts noted noise on the competitor right atrial an right ventricular lead.Oversensing was also noted as well as fluctuating amplitudes on both leads, and fluctuating pace impedance measurement on the right ventricular lead.Ts discussed a possible issue with the leads and recommended bringing the patient in for additional troubleshooting.It was also noted that the physician believed a possible fibrosis issue which would explain the noted noise.At this time the device remains implanted.No adverse patient effects were reported.Additional information noted that the device was reprogrammed and no further action was done when it comes to this case.

• Brand Name: ACCOLADE MRI EL 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; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9105712
• MDR Text Key: 160096747
• Report Number: 2124215-2019-18813
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2018
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 740222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1