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); High impedance (1291); Over-Sensing (1438); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285); Inappropriate or Unexpected Reset (2959); High Capture Threshold (3266)

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

Event Date 04/03/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this pacemaker system exhibited noise with oversensing on the right atrial (ra) lead and noise on the right ventricular (rv) lead with possible crosstalk oversensing.In addition, one atrial tachy response (atr) episode showed a single beat of rv loss of capture (loc).Technical services (ts) reviewed troubleshooting options.This pacemaker system remains in service.No adverse patient effects were reported.

Manufacturer Narrative

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

Event Description

It was reported that this pacemaker system exhibited noise with oversensing on the right atrial (ra) lead and noise on the right ventricular (rv) lead with possible crosstalk oversensing.In addition, one atrial tachy response (atr) episode showed a single beat of rv loss of capture (loc).Technical services (ts) reviewed troubleshooting options.This pacemaker system remains in service.No adverse patient effects were reported.Additional information received reported that this pacemaker had entered safety mode and recorded codes 0xa 0xa 0xa, indicative of an oscillator mismatch.There was a continuation of noise observed on both the right atrial (ra) and right ventricular (rv) leads.Review of ra impedance trends showed impedance fluctuations between 500 and 1000 ohms, and rv impedance trends indicated a decrease in pace impedance measurements from 600 ohms to as low as 481 ohms.Additionally, rv threshold measurements showed occasionally spikes from 0.9v to 3v.The pacemaker was explanted and replaced, and the rv lead was surgically abandoned and replaced during the same procedure.The ra lead remains in service.No additional adverse patient effects were reported.This pacemaker is expected to be returned for analysis.

• 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: 16850809
• MDR Text Key: 314365118
• Report Number: 2124215-2023-20984
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

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: 05/12/2017
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 708918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 05/01/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2015
• 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: 61 YR
• Patient Sex: Male