MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; IMPLANTABLE PULSE GENERATOR (PACEMAKER)

Model Number	S201
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Connection Problem (2900); Impedance Problem (2950); Material Integrity Problem (2978); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If the product is returned, analysis would be performed and this report would be updated at that time.
Event or Problem Description
It was reported that this implantable pulse generator (pacemaker) was explanted and replaced due to normal battery depletion, but also due to suspicions of interaction issues with the left atrium (la) lead.Reportedly, impedance issues, high capture thresholds and noise events were noticed for months, and it was believed there was an integrity issue with the la lead.However, during the replacement procedure, the lead was tested in the analyzer and no inadequate measurements were noticed.Thus, it was decided to keep the lead implanted and only the pacemaker was replaced.In addition, it was stated that the patient fell a few times over the last months, not related to this pacemaker performance, and it was suspected that this caused the connection issue.This pacemaker is expected to be returned for analysis and no additional adverse patient effects were reported.
Additional Manufacturer Narrative
If the product is returned, analysis would be performed and this report would be updated at that time.Upon receipt at our post market quality assurance laboratory, this implantable pulse generator (pacemaker) was thoroughly inspected and analyzed.Visual inspection found no anomalies.The analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.
Event or Problem Description
It was reported that this implantable pulse generator (pacemaker) was explanted and replaced due to normal battery depletion, but also due to suspicions of interaction issues with the left atrium (la) lead.Reportedly, impedance issues, high capture thresholds and oversensed noise events were noticed for months, and it was believed there was an integrity issue with the la lead.However, no pacing inhibition or asystole was noticed, the patient always had an intrinsic beat.Reportedly, during the replacement procedure, the lead was tested in the analyzer and no inadequate measurements were noticed.Thus, it was decided to keep the lead implanted and only the pacemaker was replaced.In addition, it was stated that the patient fell a few times over the last months, not related to this pacemaker performance, and it was suspected that this caused the connection issue.This pacemaker was returned for analysis and no additional adverse patient effects were reported.

• Brand Name: ALTRUA 20
• Common Device Name: IMPLANTABLE PULSE GENERATOR (PACEMAKER)
• 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: 15059875
• Report Number: 2124215-2022-26465
• Device Sequence Number: 20215945
• Product Code: LWP
• UDI-Device Identifier: 00802526484384
• UDI-Public: 00802526484384
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/03/2014
• Device Model Number: S201
• Device Catalogue Number: S201
• Device Lot Number: 119778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 11 YR
• Patient Sex: Male