MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 40; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S403
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
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
Boston scientific received information that it was noted that this pacemaker battery was draining and had one year left.Moreover, the physician opted to replace the device.An attempt to obtain additional pertinent information was unsuccessful.This pacemaker was explanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, an external visual inspection noted scratches and tool marks on the case.The seal plugs were intact, and the set screws operated normally.A review of the device memory noted no resets, errors, or fault codes.Manual electrical measurements noted normal sensing and pacemaker functions.Analysis showed that the device was operating normally.Laboratory analysis did not confirm the reported allegation.
Event or Problem Description
Boston scientific received information that it was noted that this pacemaker battery was draining and had one year left.Moreover, the physician opted to replace the device.An attempt to obtain additional pertinent information was unsuccessful.This pacemaker was explanted.No additional adverse patient effects were reported.

• Brand Name: ALTRUA 40
• 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: 8324107
• Report Number: 2124215-2019-03215
• Device Sequence Number: 1691422
• Product Code: LWP
• UDI-Device Identifier: 00802526484445
• UDI-Public: 00802526484445
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/02/2015
• Device Model Number: S403
• Device Catalogue Number: S403
• Device Lot Number: 592557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR