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

Model Number L301

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)

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

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this pacemaker and right ventricular (rv) lead had previously triggered a lead safety switch (lss) to unipolar due to a high out-of-range pace impedance measurement greater than 2,000 ohms.At that time, it was recommended that the device remain in unipolar due to noise.The rv lead was later programmed back to bipolar pace/sense.Subsequently, another lss occurred, and oversensed noise with pacing inhibition was observed.It was noted that there were no pauses greater than 2 seconds, as the patient had an underlying rhythm above 30 bpm.Technical services (ts) recommended programming the rv in a split configuration.Additional information received reported that this rv lead was surgically abandoned and replaced due to these observations.The pacemaker was also explanted and replaced, as it was approaching elective replacement indicator (eri).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 determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this pacemaker and right ventricular (rv) lead had previously triggered a lead safety switch (lss) to unipolar due to a high out-of-range pace impedance measurement greater than 2,000 ohms.At that time, it was recommended that the device remain in unipolar due to noise.The rv lead was later programmed back to bipolar pace/sense.Subsequently, another lss occurred, and oversensed noise with pacing inhibition was observed.It was noted that there were no pauses greater than 2 seconds, as the patient had an underlying rhythm above 30 bpm.Technical services (ts) recommended programming the rv in a split configuration.Additional information received reported that this rv lead was surgically abandoned and replaced due to these observations.The pacemaker was also explanted and replaced, as it was approaching elective replacement indicator (eri).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
• 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: 16056857
• MDR Text Key: 306216067
• Report Number: 2124215-2022-55213
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559174
• UDI-Public: 00802526559174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/02/2018
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 732659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2016
• 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): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female