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

Model Number N140

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fainting (1847)

Event Date 09/14/2018

Event Type  Injury  

Event Description

It was reported that this patient with cardiac resynchronization therapy defibrillator (crt-d) had fainted, and they were waiting for the transmission.Additional information was requested, however no further information was available.The device remains in-service.No additional adverse patient effects were reported.

• Brand Name: ENERGEN CRT-D
• 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: 8000189
• MDR Text Key: 124849319
• Report Number: 2124215-2018-60248
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480959
• UDI-Public: 802526480959
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/03/2016
• Device Model Number: N140
• Device Catalogue Number: N140
• Device Lot Number: 115364
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2014
• 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): Life Threatening
• Patient Age: 83 YR