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

Model Number	S601
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there were concerns regarding alleged premature battery depletion of this pacemaker.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that there were concerns regarding alleged premature battery depletion of this pacemaker.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned pacemaker was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Having met the engineering longevity prediction, with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.

• 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: 12643481
• Report Number: 2124215-2021-30980
• Device Sequence Number: 3452155
• Product Code: LWP
• UDI-Device Identifier: 00802526484469
• UDI-Public: 00802526484469
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2021

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: 06/04/2012
• Device Model Number: S601
• Device Catalogue Number: S601
• Device Lot Number: 144391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 12/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown