MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE DEVICE

Model Number S603

Device Problem Migration (4003)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191); Swelling/ Edema (4577)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this pacemaker was explanted and replaced after the patient felt pain and swelling around the device, there was no infection.The patent has been feeling the swelling on an off for years.It was determined that the device migrated.No additional adverse patient effects were reported.

Manufacturer Narrative

Normal device operation was noted during analysis.No visual irregularities noted, and normal battery depletion was noted.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.

Event Description

It was reported that this pacemaker was explanted and replaced after the patient felt pain and swelling around the device, there was no infection.The patent has been feeling the swelling on an off for years.It was determined that the device migrated.No additional adverse patient effects were reported.

• Brand Name: ALTRUA 60
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10617050
• MDR Text Key: 209553842
• Report Number: 2124215-2020-16834
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526484483
• UDI-Public: 00802526484483
• Combination Product (y/n): N
• PMA/PMN Number: N970003/S096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/11/2014
• Device Model Number: S603
• Device Catalogue Number: S603
• Device Lot Number: 959392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR