MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; PULSE-GENERATOR, SINGLE CHAMBER, SINGLE

Model Number J172

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

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 Description

It was reported during a routine follow up appointment this pacemaker device and competitors rv lead, had noise, oversensing on the rv channel, which lead to pacing inhibition.There was an unknown duration of asystole.The device was reprogrammed and remains implanted.No adverse patient effects were reported.Technical service consultant discussed having the patient return to clinic for additional evaluation of the rv lead.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated.

• Brand Name: INGENIO
• Type of Device: PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
• 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: 9550086
• MDR Text Key: 174668619
• Report Number: 2124215-2019-26142
• Device Sequence Number: 1
• Product Code: LWW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/24/2015
• Device Model Number: J172
• Device Catalogue Number: J172
• Device Lot Number: 105922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1