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

Model Number K173

Device Problems Failure to Capture (1081); Pacing Problem (1439); Data Problem (3196)

Patient Problems Bradycardia (1751); Convulsion/Seizure (4406); Syncope/Fainting (4411)

Event Date 11/16/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this patient with this pacemaker experienced a syncopal episode.It was noted that the health care professional (hcp) observed pauses in pacing however, technical services (ts) noted it appeared that this patient experienced atrial tachycardia and once it abated, this patient became bradycardic and pacemaker bigeminy at a slow rate.Slow paced rates with the rythmiq algorithm were observed in which ts recommended turning off.Shortly thereafter, this patient experienced a seizure and right ventricular (rv) capture could not be confirmed.This pacemaker remains in service.No adverse patient effects were reported.

• Brand Name: INGENIO
• 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: 15846619
• MDR Text Key: 304167589
• Report Number: 2124215-2022-48508
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526516825
• UDI-Public: 00802526516825
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2014
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 114470
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male