MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 40; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S403
Medical Device Problem Codes	Premature Discharge of Battery (1057); Telemetry Discrepancy (1629); Battery Problem (2885); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received a supplemental report will be submitted.
Event or Problem Description
It was reported that this pacemaker experienced difficulty being interrogated.Technical services (ts) walked the health care professional through troubleshooting including the use of a magnet and a different programmer wand.It was discovered the device was at end of life.Ts discussed that telemetry placed a large strain on the battery of the device which resulted in difficulty interrogating the device and recommended device replacement.It was noted that the patient was not pacemaker dependent at that time.The device remains in service at this time.No adverse patient effects were reported.

• Brand Name: ALTRUA 40
• 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: 12139518
• Report Number: 2124215-2021-18538
• Device Sequence Number: 14319920
• Product Code: LWP
• UDI-Device Identifier: 00802526484445
• UDI-Public: 00802526484445
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/27/2012
• Device Model Number: S403
• Device Catalogue Number: S403
• Device Lot Number: 581716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR