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

Model Number	S602
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker showed a battery status of 1 year remaining with a magnet rate of 90 paces per minute (ppm) 10 months ago.A device technician then changed the right ventricular (rv) output from auto 2.2 volts to a fixed output of 3.0 volts.The battery status then showed 3 years remaining with a magnet rate of 90 ppm.The device was then scheduled to be explanted.Prior to explant of the device, a device technician programmed the device to vvi 40 and the battery status went to 4.5 years remaining.The device was explanted and replaced with a non-boston scientific device.The physician requested more information regarding the battery status behavior.A copy of device data was submitted to technical services (ts) for review.Review of stored device data noted that the data sent did not confirm that elective replacement indicator (eri) had been reached.Ts discussed the device battery status indicators and longevity remaining that is estimated by the programmer.Ts then indicated that the reported clinical observations were a result of the change in outputs, which, impacted the longevity remaining estimated by the programmer.No additional adverse patient effects were reported.It was reported that the device was discarded by the hospital following explant and will not be returned.If information is provided in the future, a supplemental report will be issued.

• 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
• 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: 15657820
• Report Number: 2124215-2022-43069
• Device Sequence Number: 15068748
• Product Code: LWP
• UDI-Device Identifier: 00802526484476
• UDI-Public: 00802526484476
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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: 10/03/2013
• Device Model Number: S602
• Device Catalogue Number: S602
• Device Lot Number: 778230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Unknown