MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S203
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician alleged the right atrial (ra) lead was broken due to the presence of noise on the ra channel.Analysis by boston scientific technical support indicated that the noise was most likely a product of myopotentials and/or background interference.It was recommended that at the next follow up, lead integrity should be tested by performing provocative maneuvers.No patient consequences were reported and additional information has been requested, but not yet received.

• Brand Name: ALTRUA 20
• 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: 8509705
• Report Number: 2124215-2019-05336
• Device Sequence Number: 1315394
• Product Code: LWP
• UDI-Device Identifier: 00802526484391
• UDI-Public: 00802526484391
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/07/2013
• Device Model Number: S203
• Device Catalogue Number: S203
• Device Lot Number: 719153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 04/12/2019
• Patient Sequence Number: 1
• Patient Age: 33 YR