MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 2 DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S702
Medical Device Problem Codes	Over-Sensing (1438); Connection Problem (2900); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that during an implant procedure, this pacemaker exhibited oversensing of noise when the rv lead was connected.The pacemaker was removed and replaced prior to pocket closure and was never in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection of the rv header bore noted an obstruction in the bore.Microscopic inspection of the obstruction determined it was similar to a white silicone seal plug.Boston scientific seal plugs are white with a clear medical adhesive around the top, while the obstruction appears to be composed entirely of opaque white silicone, and is therefore most likely a competitor seal plug from a different device present during the implant procedure.
Event or Problem Description
It was reported that during an implant procedure, this pacemaker exhibited oversensing of noise when the rv lead was connected.The pacemaker was removed and replaced prior to pocket closure and was never in service.No adverse patient effects were reported.

• Brand Name: ALTRUA 2 DR
• 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: 8872200
• Report Number: 2124215-2019-17102
• Device Sequence Number: 2883359
• Product Code: LWP
• UDI-Device Identifier: 00802526559341
• UDI-Public: 00802526559341
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 705331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 11/06/2019
• Patient Sequence Number: 1