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

Model Number L331

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Failure to Sense (1559); Connection Problem (2900)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 01/01/2013

Event Type  Injury  

Event Description

It was reported that this pacemaker system triggered a lead safety switch (lss) due to a high out of range right ventricular (rv) lead pace impedance measurement of greater than 2000 ohms.Additionally, there was noise present on the rv lead, but it was not sensed by the device therefore, no pacing inhibiting occurred.Technical services (ts) was consulted and offered troubleshooting and programming options.Upon further review, the rv lead impedance measurement have been gradually increasing over the past two years.Patient was brought into the clinic for further follow up and device reprogramming.At this time this pacemaker system remains in service.No adverse patient effects were reported.

Event Description

It was reported that this pacemaker system triggered a lead safety switch (lss) due to a high out of range right ventricular (rv) lead pace impedance measurement of greater than 2000 ohms.Additionally, there was noise present on the rv lead, but it was not sensed by the device therefore, no pacing inhibiting occurred.Technical services (ts) was consulted and offered troubleshooting and programming options.Upon further review, the rv lead impedance measurement have been gradually increasing over the past two years.Patient was brought into the clinic for further follow up and device reprogramming.Subsequently, the patient underwent an rv lead revision procedure and during that procedure, while attempting to re-insert the right atrial (ra) lead into the device header, it was noted upon connection, the atrial electrogram (egm) did not display, therefore unable to sense.The device was successfully explanted and replaced.The rv lead was surgically abandoned and replaced.The ra lead remains in service with appropriate sensing reported at this time.No adverse patient effects were reported.

Manufacturer Narrative

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 this pacemaker system triggered a lead safety switch (lss) due to a high out of range right ventricular (rv) lead pace impedance measurement of greater than 2000 ohms.Additionally, there was noise present on the rv lead, but it was not sensed by the device therefore, no pacing inhibiting occurred.Technical services (ts) was consulted and offered troubleshooting and programming options.Upon further review, the rv lead impedance measurement have been gradually increasing over the past two years.Patient was brought into the clinic for further follow up and device reprogramming.Subsequently, the patient underwent an rv lead revision procedure and during that procedure, while attempting to re-insert the right atrial (ra) lead into the device header, it was noted upon connection, the atrial electrogram (egm) did not display, therefore unable to sense.The device was successfully explanted and replaced.The rv lead was surgically abandoned and replaced.The ra lead remains in service with appropriate sensing reported at this time.No adverse patient effects were reported.

• 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
• MDR Report Key: 11227970
• MDR Text Key: 228626072
• Report Number: 2124215-2021-01904
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• Combination Product (y/n): N
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2021

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: 07/09/2022
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 890006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 01/25/2021; 08/18/2021
• Supplement Dates FDA Received: 02/21/2021; 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR