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

Model Number L321

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285)

Patient Problems Palpitations (2467); No Code Available (3191); Unspecified Heart Problem (4454)

Event Date 03/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this patient with this dual chamber pacemaker system triggered a lead safety switch (lss) due to a low out of range right ventricular (rv) pacing impedance measurement of less than 200 ohms.Upon further investigation, it was found that the right atrial (ra) lead and right ventricular (rv) lead exhibited noise with no oversensing present.In addition, multiple atrial tachy response (atr) episodes were inappropriately stored as a result of the noise.Technical services was consulted and recommended programming and troubleshooting recommendations.The patient was brought into the clinic for further evaluation.The patient is not dependent.The physician opted to reprogram the device and not intervene at that time.Days after the device reprogramming occurred in clinic, the physician was informed that the patient's device had entered safety mode.When the device entered safety mode, the patient reported feeling their heart pounding when bending over.It was recommended that this device be replaced.Subsequently, the device was explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that this patient with this dual chamber pacemaker system triggered a lead safety switch (lss) due to a low out of range right ventricular (rv) pacing impedance measurement of less than 200 ohms.Upon further investigation, it was found that the right atrial (ra) lead and right ventricular (rv) lead exhibited noise with no oversensing present.In addition, multiple atrial tachy response (atr) episodes were inappropriately stored as a result of the noise.Technical services was consulted and recommended programming and troubleshooting recommendations.The patient was brought into the clinic for further evaluation.The patient is not dependent.The physician opted to reprogram the device and not intervene at that time.Days after the device reprogramming occurred in clinic, the physician was informed that the patient's device had entered safety mode.When the device entered safety mode, the patient reported feeling their heart pounding when bending over.It was recommended that this device be replaced.Subsequently, the device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Code 3191 was used to capture the additional intervention required upon receipt at our post market quality assurance laboratory, a thorough evaluation of the product was performed.Review of device memory confirmed the presence of a higher than normal current drain condition.Electrical testing and analysis were then conducted, which isolated the high current to an anomaly in an oxide layer within a custom integrated circuit component.This anomaly caused a high current drain, which over time resulted in the reported clinical observations.

• Brand Name: ACCOLADE 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: 11181962
• MDR Text Key: 227489316
• Report Number: 2124215-2020-28256
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559242
• UDI-Public: 00802526559242
• 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,health
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/07/2018
• Device Model Number: L321
• Device Catalogue Number: L321
• Device Lot Number: 718223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR