MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; PACEMAKER

Model Number	S602
Medical Device Problem Codes	Premature Discharge of Battery (1057); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the battery of this pacemaker was suspected to be depleting prematurely, but the timeframe in which the change in the estimated remaining battery longevity was observed, has not been specified.The physician decided to explant and replace the device.At this time, there is no evidence that suggests data analysis was performed prior to the explant procedure to confirm the premature battery depletion (pbd) observation.No additional adverse patient effects were reported.The product is expected to return for analysis.
Event or Problem Description
It was reported that the battery of this pacemaker was suspected to be depleting prematurely, but the timeframe in which the change in the estimated remaining battery longevity was observed, has not been specified.The physician decided to explant and replace the device.At this time, there is no evidence that suggests data analysis was performed prior to the explant procedure to confirm the premature battery depletion (pbd) observation.No additional adverse patient effects were reported.The product was received for analysis.
Additional Manufacturer Narrative
Patient identifier number was added to the patient information tab.The product has been received for analysis.This report will be updated upon completion of analysis, should further pertinent information be provided.
Additional Manufacturer Narrative
Patient identifier number was added to the patient information tab.The product has been received for analysis.This report will be updated upon completion of analysis, should further pertinent information be provided.The returned device 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.Next, a series of diagnostic tests were conducted that verified the performance of pacing and sensing functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
Event or Problem Description
It was reported that the battery of this pacemaker was suspected to be depleting prematurely, but the timeframe in which the change in the estimated remaining battery longevity was observed, has not been specified.The physician decided to explant and replace the device.At this time, there is no evidence that suggests data analysis was performed prior to the explant procedure to confirm the premature battery depletion (pbd) observation.No additional adverse patient effects were reported.The product was returned for analysis.

• Brand Name: ALTRUA 60
• Common Device Name: PACEMAKER
• 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: 15157939
• Report Number: 2124215-2022-28860
• Device Sequence Number: 5268155
• Product Code: LWP
• UDI-Device Identifier: 00802526484476
• UDI-Public: 00802526484476
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2022

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: 10/05/2011
• Device Model Number: S602
• Device Catalogue Number: S602
• Device Lot Number: 594979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 10/11/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 08/09/2022; 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2009
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown