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

Model Number L301

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 07/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been returned at this time.If the device is returned, analysis will be performed and this report will be updated.

Event Description

It was reported that the patient with this pacemaker underwent a magnetic resonance imaging (mri) scan.After the mri, noise and oversensing were noted on the right ventricular (rv) lead channel, and loss of capture was observed as well.It was noted the patient had an underlying rhythm in the 40 beats per minute (bpm) range.A surgical revision was performed, and when a new rv lead was implanted with this device, continued noise was observed.The device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 is being used to capture the additional intervention performed.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that the patient with this pacemaker underwent a magnetic resonance imaging (mri) scan.After the mri, noise and oversensing were noted on the right ventricular (rv) lead channel, and loss of capture was observed as well.It was noted the patient had an underlying rhythm in the 40 beats per minute (bpm) range.A surgical revision was performed, and when a new rv lead was implanted with this device, continued noise was observed.The device was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10618074
• MDR Text Key: 209545374
• Report Number: 2124215-2020-15451
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559174
• UDI-Public: 00802526559174
• Combination Product (y/n): N
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/08/2017
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 704355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR