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

Model Number	S201
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the field was unable to establish telemetry with this pacemaker.Surgical intervention was then performed to explant and replaced the device.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the field was unable to establish telemetry with this pacemaker.Surgical intervention was then performed to explant and replaced the device.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed.The device was observed to have no telemetry.The device case was removed and the battery was removed from the circuit and tested.Based on analysis of the device memory, it was observed that the device exhibited normal battery depletion.The cause of the inability to interrogate the device in the field was due to a normal depletion.

• 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: 10228066
• Report Number: 2124215-2020-11845
• Device Sequence Number: 14059877
• Product Code: LWP
• UDI-Device Identifier: 00802526484384
• UDI-Public: 00802526484384
• 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: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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: 03/21/2014
• Device Model Number: S201
• Device Catalogue Number: S201
• Device Lot Number: 118246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 01/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention