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

Model Number J067

Device Problem Pacing Problem (1439)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient implanted with this pacemaker was exhibiting a slow pulse, around 40-42 bpm.It was suspected that the device was not working properly and was not maintaining the patient's pulse at a correct rate.It was noted the device had been implanted in 2015 and these issues began within the past few days.Technical services referred the patient to their physician to have the device interrogated, as boston scientific would not have access to the device's programming.No adverse patient effects were reported.Available information indicates the device remains implanted and in service.

• Brand Name: ADVANTIO
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10775651
• MDR Text Key: 214330237
• Report Number: 2124215-2020-23273
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/09/2017
• Device Model Number: J067
• Device Catalogue Number: J067
• Device Lot Number: 390095
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR