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

Model Number K173

Device Problems Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 06/21/2019

Event Type  Injury  

Event Description

It was reported that this pacemaker system exhibited noise and oversensing on the right ventricular (rv) lead, which resulted in pacing inhibition.The patient experienced greater than 2 seconds of asystole.The patient's rv lead is a non-boston scientific product.Troubleshooting was performed, and the noise was unable to be recreated.Subsequently, a revision procedure was performed.The pacemaker was explanted and replaced, and the rv lead was surgically abandoned and replaced.No additional 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8818719
• MDR Text Key: 151955042
• Report Number: 2124215-2019-14385
• 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: Physician
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/13/2016
• Device Model Number: K173
• Device Catalogue Number: K173
• Device Lot Number: 166398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2014
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR