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

Model Number	S204
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581)
Health Effect - Clinical Codes	Bradycardia (1751); Dizziness (2194)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this pacemaker and right ventricular (rv) lead exhibited noise with oversensing pacing inhibition with greater than two seconds of asystole.It was noted that r-waves were 3.3 mv and it was programmed to 1.5mv.The patient was experiencing lightheadedness.The pacemaker was explanted, the right ventricular (rv) lead was surgically abandoned, and a new pacemaker system was successfully implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.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 baseline testing completed on the device found no failing conditions.All testing completed on the device passed or was not applicable.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 pacemaker and right ventricular (rv) lead exhibited noise with oversensing pacing inhibition with greater than two seconds of asystole.It was noted that r-waves were 3.3 mv and it was programmed to 1.5mv.The patient was experiencing lightheadedness.The pacemaker was explanted, the right ventricular (rv) lead was surgically abandoned, and a new pacemaker system was successfully implanted.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
• MDR Report Key: 12243312
• Report Number: 2124215-2021-21631
• Device Sequence Number: 11700239
• Product Code: LWP
• UDI-Device Identifier: 00802526499128
• UDI-Public: 00802526499128
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/29/2016
• Device Model Number: S204
• Device Catalogue Number: S204
• Device Lot Number: 568050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR