MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; PACEMAKER

Model Number	S208
Medical Device Problem Codes	Device Sensing Problem (2917); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient was presented for an office check.Upon interrogation, the health care professional reached out to technical services (ts) to review the presenting electrograms (egm).Upon review, it was noted that the patient has frequent premature ventricular contraction (pvc)s.It was also reported that the patient has previously undergone an ablation procedure due to an underlying patient condition.Device testing was performed and all measurements were reported to be within normal range.Subsequently, the patient underwent a right ventricular (rv) lead revision procedure.During the procedure, the physician requested the device to be reprogrammed prior to the new rv lead being inserted.Post device reprogramming, it was noted that the device was no longer pacing in the rv and the pace and sense configuration had changed, therefore additional reprogramming was performed.Ts was consulted and could not confirm the reason for this rv lead configuration change, but recommended the device be sent in for further analysis.Ultimately, the physician opted to explant and replace the pacemaker.The rv lead was successfully surgically abandoned and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.
Event or Problem Description
It was reported that this patient was presented for an office check.Upon interrogation, the health care professional reached out to technical services (ts) to review the presenting electrograms (egm).Upon review, it was noted that the patient has frequent premature ventricular contraction (pvc)s.It was also reported that the patient has previously undergone an ablation procedure due to an underlying patient condition.Device testing was performed and all measurements were reported to be within normal range.Subsequently, the patient underwent a right ventricular (rv) lead revision procedure.During the procedure, the physician requested the device to be reprogrammed prior to the new rv lead being inserted.Post device reprogramming, it was noted that the device was no longer pacing in the rv and the pace and sense configuration had changed, therefore additional reprogramming was performed.Ts was consulted and could not confirm the reason for this rv lead configuration change, but recommended the device be sent in for further analysis.Ultimately, the physician opted to explant and replace the pacemaker.The rv lead was successfully surgically abandoned and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, analysis of the returned device found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.The device was subjected to and passed all automated testing.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.The product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.

• Brand Name: ALTRUA 20
• 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: 14911436
• Report Number: 2124215-2022-24059
• Device Sequence Number: 20364962
• Product Code: LWP
• UDI-Device Identifier: 00802526484421
• UDI-Public: 00802526484421
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S106
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: 08/16/2013
• Device Model Number: S208
• Device Catalogue Number: S208
• Device Lot Number: 597788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 07/04/2022
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2011
• 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: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male