MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S603
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while performing a device check, this pacemaker was unable to perform the right ventricular (rv) lead impedance test.Technical services (ts) was consulted and discussed troubleshooting options.Subsequently, the device was explanted and replaced.No additional adverse patient effects were reported.This product has been returned for analysis.This report will be updated should additional information become available or when analysis is completed.
Event or Problem Description
It was reported that while performing a device check, this pacemaker was unable to perform the right ventricular (rv) lead impedance test.Technical services (ts) was consulted and discussed troubleshooting options.Subsequently, the device was explanted and replaced.No additional adverse patient effects were reported.This product has been returned for analysis.This report will be updated should additional information become available or when analysis is completed.
Additional Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported inability to perform the right ventricular (rv) lead impedance test.

• Brand Name: ALTRUA 60
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12618712
• Report Number: 2124215-2021-20547
• Device Sequence Number: 19701289
• Product Code: LWP
• UDI-Device Identifier: 00802526484483
• UDI-Public: 00802526484483
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 02/15/2014
• Device Model Number: S603
• Device Catalogue Number: S603
• Device Lot Number: 953026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 10/13/2021
• 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: 83 YR