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

Model Number	S722
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device has been returned back from the field for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that during an implant procedure, this pacemaker was connected to the leads however the field was unable to establish telemetry and interrogate it.Despite troubleshooting, the physician could not resolve the issue so the pacemaker was removed and replaced prior to pocket closure.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that during an implant procedure, this pacemaker was connected to the leads however the field was unable to establish telemetry and interrogate it.Despite troubleshooting, the physician could not resolve the issue so the pacemaker was removed and replaced prior to pocket closure.No adverse patient effects were reported.

• Brand Name: ALTRUA 2 EL 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: 8562894
• Report Number: 2124215-2019-08028
• Device Sequence Number: 11195482
• Product Code: LWP
• UDI-Device Identifier: 00802526559365
• UDI-Public: 00802526559365
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Lay User/Patient
• Device Expiration Date: 07/26/2020
• Device Model Number: S722
• Device Catalogue Number: S722
• Device Lot Number: 701856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 11/06/2019
• Patient Sequence Number: 1